Gastrointestinal Cancer Clinical Trials
When appropriate, we also offer our patients the option to participate in clinical trials to try a promising new medical drug or other treatment. New treatments through clinical trials are expected to be at least as effective as — or possibly more effective than — current treatments.
Clinical trials test new treatment options only after they have first been researched in the laboratory, where they are carefully studied in the test tube and in laboratory animals. Only the treatments most likely to work are further evaluated in humans during clinical trials. For any new drug or treatment to receive approval by the U.S. Food and Drug Administration (FDA) and become available to the public, it must pass through three phases of clinical trials to show that it is safe and effective in treating the disease. If the FDA approves the drug, it will continue to be monitored for safety and effectiveness in what is known as a Phase 4 study.
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Phase I Open-Label, Dose Escalation Trial of BI 1831169 Monotherapy and in Combination with an Anti-PD-1 mAb in Patients with Advanced or Metastatic Solid Tumors. +
Phase I Open-Label, Dose Escalation Trial of BI 1831169 Monotherapy and in Combination with an Anti-PD-1 mAb in Patients with Advanced or Metastatic Solid Tumors.
Protocol No: 1456-0001
Age Group: Adult
Disease Sites: Eye and Orbit, Lip, Oral Cavity and Pharynx, Pancreas
NCT Id: NCT05155332
Phase: I
Principal Investigators: Tirrell Johnson, MD
Eligibility Document -
Attachment Id: 14732
File Name: UPDATED Subject Eligibility _Screening Checklist_1456-001_Part One (2).docx
URL:
Objective
To determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) for BI 1831169 both as monotherapy and in combination with an anti-PD-1 antibody and to assess the efficacy, safety and tolerability when given via intravenous and intratumoral routes.
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A Phase 3 Randomized, Double-blind, Placebo-controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants with Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations who are Ineligible for Intensive Chemotherapy +
A Phase 3 Randomized, Double-blind, Placebo-controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants with Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations who are Ineligible for Intensive Chemotherapy
Protocol No: 75276617AML3001
Age Group: Adult
Disease Sites: Myeloid and Monocytic Leukemia
NCT Id: NCT06852222
Phase: III
Principal Investigators: Juan Varela MD, PhD
Eligibility Document -
Attachment Id: 16972
File Name: Subject Eligibility _Screening Checklist_JNJ75276617AML3001.docx
URL:
Objective
The primary objective is to determine whether the addition of bleximenib to VEN+AZA significantly improves the dual primary endpoints of CR rate or OS compared with VEN+AZA in participants with ND KMT2Ar or NPM1mAML who are ineligible for intensive chemotherapy
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A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) with Newly Diagnosed Precursor B-Cell ALL +
A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) with Newly Diagnosed Precursor B-Cell ALL
Protocol No: A041501
Age Group: Adult
Disease Sites: Leukemia, other
NCT Id: NCT03150693
Phase: III
Principal Investigators: Jose Sarriera, MD
Objective
The main goal of this study is to find out if adding inotuzumab ozogamicin to standard chemotherapy works better than chemotherapy alone for treating young adults with newly diagnosed B-cell acute lymphoblastic leukemia, and to see how safe this combination is.
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A Randomized, Open-Label Study Evaluating the Efficacy and Safety of Cemacabtagene Ansegedleucel in Participants with Minimal Residual Disease After Response to First Line Therapy for Large B-Cell Lymphoma (Alpha3) +
A Randomized, Open-Label Study Evaluating the Efficacy and Safety of Cemacabtagene Ansegedleucel in Participants with Minimal Residual Disease After Response to First Line Therapy for Large B-Cell Lymphoma (Alpha3)
Protocol No: ALLO-501A-202
Age Group: Adult
Disease Sites: Non-Hodgkin's Lymphoma
NCT Id: NCT06500273
Phase: II
Principal Investigators: Juan Varela MD, PhD
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A Phase 3, Multi-Center, Randomized, Open-Label Clinical Study of Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy as First-Line Treatment in Patients with Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma +
A Phase 3, Multi-Center, Randomized, Open-Label Clinical Study of Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy as First-Line Treatment in Patients with Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Protocol No: BGB-A317-316
Age Group: Adult
Disease Sites: Esophagus, Stomach
NCT Id: NCT07043400
Phase: III
Principal Investigators: Raji Shameem, MD
Objective
This study is testing two different ways of giving a medicine called tislelizumab to patients with advanced stomach or gastroesophageal junction (GEJ) cancer. One way is by injection under the skin (called SC injection) and the other is through a vein (IV infusion). Both methods are given along with chemotherapy.
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A Randomized, Phase 3 Study of Rilvegostomig in Combination with Fluoropyrimidine and Trastuzumab Deruxtecan Versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First Line Treatment of HER2-positive Gastric Cancer (ARTEMIDE-Gastric01) +
A Randomized, Phase 3 Study of Rilvegostomig in Combination with Fluoropyrimidine and Trastuzumab Deruxtecan Versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First Line Treatment of HER2-positive Gastric Cancer (ARTEMIDE-Gastric01)
Protocol No: D702AC00001
Age Group: Adult
Disease Sites: Gastric Disease
NCT Id: NCT06764875
Phase: III
Principal Investigators: Jacobo Hincapie-Echeverri, MD
Objective
To find out if adding the medicine rilvegostomig to trastuzumab deruxtecan and chemotherapy works better and is as safe as the current standard treatment of pembrolizumab with trastuzumab and chemotherapy for people with HER2 positive stomach or GE junction cancer that has spread or cannot be removed.
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Phase 1b/2a Study of GNS561 in Combination with Trametinib in Advanced KRAS Mutated Cholangiocarcinoma +
Phase 1b/2a Study of GNS561 in Combination with Trametinib in Advanced KRAS Mutated Cholangiocarcinoma
Protocol No: GNS561-222-1
Age Group: Adult
Disease Sites: Bile Duct Cancer (Cholangiocarcinoma)
NCT Id: NCT05874414
Phase: I/II
Principal Investigators: Omar Kayaleh, MD
Objective
This study will evaluate the safety of the drug combination GNS561 and trametinib and determine whether any significant treatment-related side effects occur during the first treatment cycle. It will also assess how well the drugs work by measuring how many patients have their tumors shrink or disappear.
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A Phase 2, Open-Label, Multicenter Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination with Gemcitabine Plus Oxaliplatin in Patients with Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma +
A Phase 2, Open-Label, Multicenter Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination with Gemcitabine Plus Oxaliplatin in Patients with Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
Protocol No: GO45434
Age Group: Adult
Disease Sites: Non-Hodgkin's Lymphoma
NCT Id: NCT06806033
Phase: II
Principal Investigators: Juan Varela MD, PhD
Eligibility Document -
Attachment Id: 14973
File Name: Subject Eligibility _Screening Checklist_GO45434.docx
URL:
Objective
This study will evaluate the optimization of the CRS profile for the Glofit-GemOx treatment regimen in patients with R/R DLBCL, using optimized regimen of steroids and a revised infusion and monitoring regimen to optimize the CRS profile of this treatment combination.
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A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC) +
A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)
Protocol No: ICONIC-A031702
Age Group: Adult
Disease Sites: Kidney, Other Male Genital, Other Urinary, Prostate, Urinary Bladder
NCT Id: NCT03866382
Phase: II
Principal Investigators: Hatem Hassanein, MD
Objective
This study tests the combination of ipilimumab, nivolumab, and cabozantinib in patients with rare genitourinary cancers, measuring how many patients respond to the treatment based on tumor shrinkage or disappearance using RECIST 1.1 criteria.
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An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants with Advanced Solid Tumors +
An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants with Advanced Solid Tumors
Protocol No: IDE397-001
Age Group: Adult
Disease Sites: Esophagus, Lung, Melanoma, Skin, Pancreas
NCT Id: NCT04794699
Phase: I
Principal Investigators: Tirrell Johnson, MD
Eligibility Document -
Attachment Id: 7934
File Name: Subject Eligibility Checklist Version 15MAR2024 final.docx
URL:
Objective
To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IDE397 alone and in combination with docetaxel or paclitaxel in adult participants with advanced solid tumors.
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (AXemplify-357) +
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (AXemplify-357)
Protocol No: INCA34176-357
Age Group: Both
Disease Sites: Other Hematopoietic
NCT Id: NCT06585774
Phase: III
Principal Investigators: Juan Varela MD, PhD
Objective
To compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe cGVHD.
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A Phase 1B Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of ATP150/ATP152, VSV-GP154 and Ezabenlimab (BI 754091) in Patients with KRAS G12D/G12V Mutated Pancreatic Ductal Adenocarcinoma (KISIMA-02) +
A Phase 1B Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of ATP150/ATP152, VSV-GP154 and Ezabenlimab (BI 754091) in Patients with KRAS G12D/G12V Mutated Pancreatic Ductal Adenocarcinoma (KISIMA-02)
Protocol No: KISIMA-02
Age Group: Adult
Disease Sites: Pancreas
NCT Id: NCT05846516
Phase: I
Principal Investigators: Omar Kayaleh, MD
Eligibility Document -
Attachment Id: 5231
File Name: Subject Eligibility _Screening Checklist KISIMA 02.docx
URL:
Objective
This study is testing a combination of new cancer-fighting drugs to see if they are safe and might help people with a specific type of pancreatic cancer (KRAS-mutated) live longer or delay the return of their cancer.
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A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE;FL-2) +
A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE;FL-2)
Protocol No: M22-003
Age Group: Adult
Disease Sites: Non-Hodgkin's Lymphoma
NCT Id: NCT06191744
Phase: III
Principal Investigators: Jose Sarriera, MD
Eligibility Document -
Attachment Id: 6409
File Name: Subject Eligibility _Screening Checklist M22-003_Version 2.0 dated 09Feb2024.docx
URL:
Objective
This study is testing if a new drug combination (epcoritamab with rituximab and lenalidomide) works better than standard chemotherapy for adults with previously untreated follicular lymphoma.
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A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 versus mFOLFOX6 with or Without Bevacizumab as First-line Treatment of Participants with KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012) +
A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 versus mFOLFOX6 with or Without Bevacizumab as First-line Treatment of Participants with KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012)
Protocol No: MK-1084-012
Disease Sites: Anus, Colon, Other Digestive Organ, Rectum
NCT Id: NCT06997497
Phase: III
Principal Investigators: Jacobo Hincapie-Echeverri, MD
Objective
To evaluate the safety and tolerability of treatment with MK-1084, cetuximab, and mFOLFOX6
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A Phase II, Open-Label, Multi-Cohort, Multicenter Study in Patients with Unresectable Hepatocellular Carcinoma and Child-Pugh B7 and B8 Cirrhosis +
A Phase II, Open-Label, Multi-Cohort, Multicenter Study in Patients with Unresectable Hepatocellular Carcinoma and Child-Pugh B7 and B8 Cirrhosis
Protocol No: ML44719
Age Group: Adult
Disease Sites: Liver
NCT Id: NCT06096779
Phase: II
Principal Investigators: Jacobo Hincapie-Echeverri, MD
Objective
This study is testing a new treatment in people with advanced liver cancer (hepatocellular carcinoma) who also have moderate liver damage. The goal is to see how safe the treatment is and to track any side effects.
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Phase 1/2 Study of mRNA-4359 Administered Alone and in Combination with Immune Checkpoint Blockade in Participants with Advanced Solid Tumors +
Phase 1/2 Study of mRNA-4359 Administered Alone and in Combination with Immune Checkpoint Blockade in Participants with Advanced Solid Tumors
Protocol No: MRNA-4359-P101
Age Group: Adult
Disease Sites: Lung, Melanoma, Skin
NCT Id: NCT05533697
Phase: I/II
Principal Investigators: Yuanbin Chen, MD
Objective
The main goal of this study is to find the safest dose of the study drug and see how well it works against solid tumors. We will also check for any side effects and how the cancer responds to treatment. This helps us learn if the drug can be used safely and effectively.
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Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease +
Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
Protocol No: NRG-GI008
Age Group: Adult
Disease Sites: Colon
NCT Id: NCT05174169
Phase: II/III
Principal Investigators: Omar Kayaleh, MD
Eligibility Document -
Attachment Id: 13913
File Name: NRG-GI008 CIRCULATE NA Subject Eligibility _Step 1-Study Entry Screening Checklist v4.0 08Jul2025.docx
URL:
Objective
This study is testing whether a blood test called ctDNA can help guide chemotherapy after surgery for stage II or III colon cancer. The goal is to see if using this test can safely reduce how many patients need chemotherapy or help give it only to who really need it, based on signs of cancer in the blood.
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SpaceIT Hydrogel System for Perirectal Spacing in Subjects with Low to Intermediate Risk Prostate Cancer Undergoing External Beam Radiotherapy (EBRT) +
SpaceIT Hydrogel System for Perirectal Spacing in Subjects with Low to Intermediate Risk Prostate Cancer Undergoing External Beam Radiotherapy (EBRT)
Protocol No: U0755
Age Group: Adult
Disease Sites: Prostate
NCT Id: NCT06451614
Phase: N/A
Principal Investigators: Akash Nanda, MD
Eligibility Document -
Attachment Id: 11457
File Name: U0755 (HYDROSPACE) Subject Eligibility _Screening Checklist_Version1.0_11Apr2025.docx
URL:
Objective
This study is testing a hydrogel device that helps protect the rectum during radiation therapy for prostate cancer. It creates space between the prostate and rectum to reduce radiation exposure and help prevent side effects.
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