Gastrointestinal Cancer

Disease Group

Gastrointestinal Cancer

Disease Group Profile

The GI Oncology Disease Group has a highly collaborative team of investigators who are committed to developing innovative therapeutic strategies for patients with significant, unmet need. We have launched disease-specific umbrella trials to identify patients with actionable molecular targets and treat those patients with best-in-class therapies. Moving forward, the GI team hopes to leverage its strengths to expand its portfolio of targets and therapies.

Disease Group Leaders

Tanios Bekaii-Saab, M.D.

ACCRU Chair, Board of Directors ChairMayo Clinic Arizona

Tanios Bekaii-Saab, M.D. is a medical oncologist focusing on the treatment of gastrointestinal malignancies. He is the leader of the gastrointestinal cancer program for the Mayo Clinic Enterprise Cancer Center. Dr. Bekaii-Saab has served on various committees for ACCRU since 2012. He currently serves as the Consortium and Board of Director Chair for ACCRU.

John Strickler, M.D.

Duke University Medical Center

John Strickler, M.D. is an Associate Professor at Duke University, where he is the Associate Director of Clinical Research – GI Oncology and Co-Leader of the Molecular Tumor Board. Dr. Strickler’s clinic specializes on the treatment of gastrointestinal malignancies, with a particular emphasis on colorectal cancer.

Disease Group Clinical Trials

2018-07

Blood and Stool Sample Collection in Subjects with a Diagnosis of Colorectal Cancer or Colorectal Lesion

Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion: Act Fast »

ACCRU-GI-1603

Phase I Study of Irinotecan Liposome (nal-IRI), Fluorouracil, Leucovorin and Rucaparib in the Treatment of Select Gastrointestinal Metastatic Malignancies Followed by a Phase Ib of First and Second Line Treatment of both Unselected and Selected ( for BRCA 1/2 and PALB2 Mutations) Patients with Metastatic Adenocarcinoma of the Pancreas then Followed by a Phase II Study of First Line Treatment of Selected Patients with Metastatic Adenocarcinoma of the Pancreas with Genomic Markers (Signature) of Homologous Recombination Deficiency (HRD)

Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer »

ACCRU-GI-1611

COLOMATE: COlorectal Cancer Liquid BiOpsy Screening Protocol for Molecularly Assigned ThErapy

Genetic Testing in Screening Patients With Metastatic or Unresectable Colon or Rectal Cancer for a COLOMATE Trial »

ACCRU-GI-1623

A Randomized, Phase II Open Label Study of PanitUmumab RechaLlenge Versus Standard Therapy after Progression on Anti-EGFR Therapy in Patients with Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer

Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer »

ACCRU-GI-1809

A Randomized Phase II Study of Regorafenib Followed by Anti-EGFR monoclonal antibody therapy Versus the Reverse Sequencing for metastatic colorectal cancer patients previously treated with fluoropyrimidine, oxaliplatin and irinotecan (REVERCE II)

Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer »

ACCRU-GI-1810

Ramucirumab Plus trifluridine/tipiracil (TAS-102) for Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: An Investigator-Initiated, Randomized Non-inferiority Phase 2 Study

Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer »

ACCRU-GI-1907

BrafPanc: A Phase II Trial of Binimetinib in combination with Encorafenib in patients with Pancreatic Malignancies and a somatic BRAFV600E mutation

Binimetinib and Encorafenib for the Treatment of Pancreatic Cancer in Patients With a Somatic BRAF V600E Mutation »

ACCRU-GI-2008

A Phase II Randomized Study of Atezolizumab plus Multi-Kinase Inhibitor Versus Multi-Kinase Inhibitor Alone in Subjects with Unresectable, Advanced Hepatocellular Carcinoma Who Previously Received Atezolizumab and Bevacizumab

Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer »

ACCRU-GI-2017

A Phase II Study of Nivolumab plus Ipilimumab in advanced HCC patients who have progressed on first-line Atezolizumab + Bevacizumab

A Phase II Study of Nivolumab + Ipilimumab in Advanced HCC Patients Who Have Progressed on First Line Atezolizumab + Bevacizumab »

ACCRU-ICRN-1701

A Phase I, Single center, Open label, Dose De-escalation and Expansion Study of gemcitabine and cisplatin with AG120 or INCB054828 for advanced cholangiocarcinoma

Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma »

ACCRU-ICRN-1702

A Phase II study of Olaparib in patients with advanced biliary tract cancer expressing aberrant DNA repair

Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations »

AG0315OG/CTC0140

INTEGRATE IIb: A Randomised Phase III Open Label Study of regorafenib + nivolumab vs standard chemotherapy in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)

RegoNivo vs Standard of Care Chemotherapy in AGOC (INTEGRATEIIb) »

ACCRU-GI-1920

Neoadjuvant Regorafenib Plus Durvalumab (MEDI4736) in Patients with High-risk Hepatocellular Carcinoma (the “Purpose”)

ACCRU-GI-2003

3T: A Phase II, Open Label Study of Tucatinib Combined with Trastuzumab and TAS-102 in Molecularly Selected Patients with HER2+ Metastatic Colorectal Cancer

2018-01

Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors

Stool Collection Sub-Study of Exact Sciences Protocol 2018-01 »

ACCRU-GI-1618

Combination of MEK Inhibitor Binimetinib and CDK4/6
Inhibitor Palbociclib in KRAS and NRAS Mutant Metastatic Colorectal Cancers

Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer »

ACCRU-GI-1701

A Phase II, Multicenter, Single-Arm Study of Pemigatinib in Patients with Metastatic Colorectal Cancer Harboring FGFR Alterations

Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations »

ARRAY-818-302

A Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetu ximab or Infusional 5-Fluorouracil (5- FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetu ximab With a Safety Lead-in of Encorafenib Binimetinib Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer

Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer (BEACON CRC) »

BBI608-336

A Phase III Clinical Trial of BBI608 Plus Weekly Paclitaxel vs. Placebo Plus Weekly Paclitaxel in Adult Patients With Advanced, Previously Treated

A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer (BRIGHTER) »

CanStem111P

A Phase III Study of BBI- 608 Plus Nab- Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinom a

A Study of Napabucasin Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma (CanStem111P) »

CanStem303C

A Phase III Study of BBI- 608 in Combination With 5- Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CRC)

A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CanStem303C) »

D-US-60010-001

An open-label, randomised, multicentre, phase III study of irinotecan liposome injection, oxaliplatin, 5-fluorouracil/leucovorin versus nab-paclitaxel plus gemcitabine in subjects who have not previously received chemotherapy for metastatic adenocarcinoma of the pancreas

A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment (NAPOLI 3) »

M14-064

Phase 2 Study Comparing Efficacy and Safety of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Metastatic Colorectal Cancer Previously Treated with Fluoropyrimidine/Oxaliplatin-Based Regimen and Bevacizumab

Phase 2 Study Comparing Efficacy and Safety of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Metastatic Colorectal Cancer Previously Treated with Fluoropyrimidine/Oxaliplatin-Based Regimen and Bevacizumab »

MC0248

A Phase I Dose-Finding Study and a Randomized Phase II Study of ALIMTA Plus Oxaliplatin Versus Oxaliplatin Plus 5-Fluorouracil and Leucovorin (FOLFOX 4 Regimen) in the First-Line Treatment of Patients With Locally Advanced Unresectable or Stage IV Colorectal Cancer

Stage IV Colorectal CA ALIMTA »

MM-111-13-02-04

Randomized, Open Label, Phase 2 Study of MM-111 and Paclitaxel With Trastuzumab in Patients With HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy

A Study of MM-111 and Paclitaxel With Trastuzumab in Patients HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach »

MORAb-004-202-CRC

A Randomized, Double-Blind, Placebo-controlled Study of the Efficacy & Safety of Monotherapy MORAb-004 Plus Best Supportive Care in Subjects With Chemorefractory Metastatic Colorectal Cancer

Morphotek Investigation in Colorectal Cancer: Research of MORAb-004 (MICRO) »

MS202202-0002

A Phase II Single-Arm Study to Investigate Tepotinib Combined with Cetuximab in RAS/BRAF Wild-Type Left- Sided Metastatic Colorectal Cancer (mCRC) Patients Having Acquired Resistance to Anti-EGFR Antibody Targeting Therapy Due to MET Amplification

Study of Tepotinib Combined With Cetuximab in Participants With Left-Sided RAS/BRAF Wild Type Metastatic Colorectal Cancer (PERSPECTIVE) (CanStem303C) »

RU021212I

Randomized Phase II Study of Adjuvant Regorafenib vs Placebo in Patients with Node Positive Esophageal Cancer that Completed Pre-operative Therapy

Regorafenib in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction Who Have Completed Chemoradiation Therapy and Surgery »

RU021302I

BOND-3:A Randomized, Double-blind, Placebo-controlled Phase II Trial of Irinotecan, Cetuximab, and Bevacizumab Compared with Irinotecan, Cetuximab, and Placebo in RAS-Wildtype, Irinotecan-refractory Metastatic Colorectal

Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With RAS Wild-Type Locally Advanced or Metastatic Colorectal Cancer That Cannot Be Removed by Surgery »

RU021407I

Regorafenib Dose Optimization Study (ReDOS): A Phase II Randomized Study of Lower Dose Regorafenib Compared to Standard Dose Regorafenib in Patients with Refractory Metastatic Colorectal Cancer (mCRC)

Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer »

RU021416I

BACCI: A Phase II Randomized, Double-Blind, Placebo- Controlled Study of Capecitabine Bevacizumab plus Atezolizumab versus Capecitabine Bevacizumab plus Placebo in Patients with Refractory Metastatic Colorectal Cancer

Capecitabine and Bevacizumab With or Without Atezolizumab in Treating Patients With Refractory Metastatic Colorectal Cancer »

RU021502I

A Multicenter Phase II Study of Pembrolizumab (MK-3475) in Patients with Advanced Small Bowel Adenocarcinoma S

Pembrolizumab in Treating Patients With Small Bowel Adenocarcinoma That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery »