Clinical Trials for Stomach Cancer

Phase IIA Single-Arm Study of Treatment of Patients With Advanced Liver Cancer With a Combination of TATE (Transarterial Tirapazamine Embolization) Followed by an Anti-PD-1 Monoclonal Antibody

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with advanced hepatocellular carcinoma (Child-Pugh A–B7) or metastatic gastric/gastroesophageal cancer with ≥1 liver lesion, who have progressed on prior immune checkpoint inhibitor therapy (or chemo plus ICI for gastric/GE), receive nivolumab (PD‑1 inhibitor) plus transarterial tirapazamine embolization (TATE), a hypoxia-activated prodrug delivered with embolization to intensify local tumor kill and potentially augment systemic immunity. Requires ECOG 0–2 and adequate organ function; excludes recent major GI bleeding and significant autoimmune disease.

ClinicalTrials.gov ID: NCT03259867

A Randomized Trial Comparing Early Local Chemoradiation Therapy +/- Surgery Versus Systemic Therapy for Patients With Esophageal or Gastric Cancer With Oligometastases

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with esophageal or gastric adenocarcinoma and oligometastatic disease (≤3 lesions) who achieve disease control after 6–8 cycles of first-line fluoropyrimidine-based chemotherapy are randomized to continue systemic therapy versus add early local therapy with chemoradiation to primary/metastatic sites, with surgery permitted. Fluorouracil or capecitabine (antimetabolite thymidylate synthase inhibitors) are used in both arms; primary endpoint is overall survival.

ClinicalTrials.gov ID: NCT03161522

A Multi-Center Phase I Trial of Neratinib and Fam-trastuzumab Deruxtecan in Advanced Refractory Gastric and Esophageal Cancer Patients

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Enrolling adults with metastatic/unresectable HER2-positive GI cancers—primarily gastroesophageal/GEJ adenocarcinoma after prior chemo plus HER2 therapy (other HER2 IHC 3+ GI tumors allowed)—with ECOG 0–2 and no prior TDxD. Patients receive daily oral neratinib (irreversible pan-HER TKI: EGFR/HER1, HER2, HER4) with q21-day IV fam-trastuzumab deruxtecan (HER2-directed ADC with topoisomerase I payload) to define safety/MTD, with attention to diarrhea and ILD risks.

ClinicalTrials.gov ID: NCT05274048

Randomized Phase III Trial of mFOLFIRINOX vs. FOLFOX With Nivolumab for First-Line Treatment of Metastatic HER2- Gastroesophageal Adenocarcinoma

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with unresectable/metastatic HER2‑negative adenocarcinoma of the esophagus/GEJ/stomach (ECOG 0–1; prior periop/adjuvant therapy allowed if >1 year) are randomized to first-line mFOLFIRINOX versus mFOLFOX, each given with or without nivolumab. Nivolumab is a PD-1 inhibitor restoring antitumor T‑cell activity; the trial tests whether adding irinotecan (FOLFIRINOX) improves outcomes over FOLFOX, with key exclusions including significant neuropathy, active autoimmune disease, and UGT1A1*28 homozygosity/Gilbert’s.

ClinicalTrials.gov ID: NCT05677490

Phase 1 Trial of Nab-Paclitaxel PIPAC (Pressurized Intraperitoneal Aerosolized Chemotherapy) Given in Combination With Second-Line Therapy for Gastric Cancer With Peritoneal Metastases

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with gastric adenocarcinoma and visible peritoneal metastases after failure of first-line fluoropyrimidine/platinum (ECOG 0–1) receive intraperitoneal nab‑paclitaxel via PIPAC added to standard second-line paclitaxel plus ramucirumab. Nab‑paclitaxel (albumin-bound paclitaxel enhancing intratumoral delivery) is dosed by PIPAC every 56 days for up to 3 cycles alongside fixed-dose systemic paclitaxel/ramucirumab to determine safety and dosing, with limited prior second-line therapy allowed.

ClinicalTrials.gov ID: NCT06675136

A Phase IIa Study of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and PD-L1 Expression in Gastric Cancer With Peritoneal Metastases

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with gastric cancer limited to peritoneal metastases or positive cytology after 2–4 months of prior chemotherapy receive repeated interval laparoscopic HIPEC with cisplatin and mitomycin C to assess PD-L1 upregulation in peritoneal tumors. Secondary aims include conversion to resectability, PCI reduction, survival, and perioperative safety, with interest in outcomes among PD-L1–positive patients who may receive systemic PD-1 inhibitors.

ClinicalTrials.gov ID: NCT04107077

A Pilot Study of Pembrolizumab and Lenvatinib Combination Therapy in Patients With Previously Treated Advanced Gastroesophageal Adenocarcinoma

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Single-arm study for adults with unresectable or metastatic gastric/GEJ adenocarcinoma after failure of prior systemic therapy, requiring measurable disease and ECOG 0–1, excluding prior PD-1/PD-L1 or VEGF/lenvatinib exposure. Patients receive pembrolizumab (anti–PD-1) plus lenvatinib (oral multikinase inhibitor of VEGFR/FGFR/PDGFR/KIT/RET) to assess response, with secondary endpoints including durability, PFS/OS, and safety.

ClinicalTrials.gov ID: NCT05041153

A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with stage IV gastric or GEJ adenocarcinoma limited to peritoneal disease (positive cytology and/or carcinomatosis) after preoperative systemic chemotherapy receive intraperitoneal paclitaxel every 2 weeks perioperatively, with gastrectomy considered at investigator discretion. Paclitaxel is a microtubule-stabilizing cytotoxic agent; HER2 therapy and PD-1 inhibitors may continue, and the trial emphasizes safety and feasibility of IP delivery and surgery in this setting.

ClinicalTrials.gov ID: NCT05977998

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

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with unresectable or metastatic gastric/GEJ adenocarcinoma progressing after fluoropyrimidine/platinum (and trastuzumab if HER2+) are randomized to ramucirumab (VEGFR-2 antibody) plus oral trifluridine/tipiracil (TAS-102, nucleoside analog with thymidine phosphorylase inhibitor) versus the standard ramucirumab plus paclitaxel as second-line therapy. Key eligibility: ECOG 0–1, adequate organ function, no prior ramucirumab/TAS-102 or recent taxane exposure, and ability to take oral therapy.

ClinicalTrials.gov ID: NCT04660760

COordinated Nivolumab and IntraperiToneal IL-2 for Gastric CanceR with PeritOneaL Metastasis (CONTROL) Phase 1b Pilot Study

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with gastric or GEJ adenocarcinoma limited to peritoneal metastases (PCI 1–24), ECOG 0–2, starting or on first-line FOLFOX plus nivolumab without progression. Adds intraperitoneal aldesleukin (IL-2; immune-stimulatory cytokine activating T cells/NK cells) on days 1 and 8 of each 14‑day cycle with standard FOLFOX+nivolumab to reduce peritoneal disease; excludes non-peritoneal mets and prior checkpoint/IL-2.

ClinicalTrials.gov ID: NCT05802056