Clinical Trials for Stomach Cancer

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

Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy

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 periampullary or distal gastric cancers causing symptomatic gastric outlet obstruction (GOOSS 0–1), including those who failed duodenal stenting, are randomized to endoscopic ultrasound-guided gastrojejunostomy versus laparoscopic surgical gastrojejunostomy. The trial compares time to resumption of solid intake and safety/functional recovery to guide palliative bypass choice.

ClinicalTrials.gov ID: NCT05561907

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 Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Gastric Cancer and Limited Peritoneal Metastasis: ROBO-CHIP Trial

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 Siewert II/III GEJ adenocarcinoma with peritoneal-only metastases and low tumor burden (PCI ≤7) after response to systemic therapy undergo robotic cytoreductive gastrectomy followed by HIPEC with cisplatin (DNA crosslinking platinum) and docetaxel (microtubule-stabilizing taxane). Trial focuses on perioperative safety and recovery metrics in this minimally invasive approach compared with historical open standards.

ClinicalTrials.gov ID: NCT05753306

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

A Phase II Study Of Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Overexpressing Gastroesophageal Cancers

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 previously untreated, HER2-overexpressing/metastatic esophageal, gastric, or GEJ adenocarcinoma (IHC 3+ or FISH+ if IHC 2+), ECOG 0–1, receive neratinib (irreversible pan-HER TKI targeting EGFR/HER2/HER4) added to mFOLFOX plus trastuzumab and pembrolizumab; treated/stable brain metastases allowed. Excludes active CNS disease, significant cardiac disease, >grade 1 neuropathy, active autoimmune disease on systemic therapy, pneumonitis, active infection, or chronic steroids >10 mg prednisone equivalent.

ClinicalTrials.gov ID: NCT06109467

Protocol EA2234: A Randomized Phase II/III Trial of Intraperitoneal Paclitaxel Plus Systemic Treatment vs Systemic Treatment Alone in Gastric Carcinomatosis - STOPGAP II

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 ECOG 0–1, microsatellite-stable/MMR-proficient gastric or Siewert type 3 GEJ adenocarcinoma with positive peritoneal cytology and/or peritoneal carcinomatosis (no solid organ metastases except ovarian) who have completed 3–6 months of first-line systemic therapy without significant radiologic peritoneal progression and are candidates for diagnostic laparoscopy/IP port placement. Patients are randomized at laparoscopy to continue physician’s-choice standard systemic therapy alone versus adding intraperitoneal plus IV paclitaxel (a microtubule-stabilizing taxane) with systemic 5-FU/leucovorin on a 21-day cycle.

ClinicalTrials.gov ID: NCT07001748