Clinical Trials for Stomach Cancer

A Phase II Clinical Trial of Anti-PD-1 mAb Therapy Alone or With Metabolic Modulators to Reverse Tumor Hypoxia and Immune Dysfunction in Solid Tumor Malignancies

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.

HealthScout AI summary: Adults with advanced solid tumors eligible for standard anti–PD-1 monotherapy (e.g., melanoma, RCC, NSCLC, HCC Child-Pugh A, MSI-H tumors, urothelial, GEJ/gastric adenocarcinoma, HNSCC) are randomized to nivolumab or pembrolizumab alone versus combined with metformin (mitochondrial complex I inhibitor/AMPK activator) or rosiglitazone (PPAR-γ agonist) to reduce tumor hypoxia and improve immune function. Requires measurable disease, ECOG 0–2, and mandatory pre/post-treatment biopsies; excludes prior PD-1/PD-L1 therapy and significant cardiopulmonary/autoimmune contraindications.

ClinicalTrials.gov ID: NCT04114136

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.

HealthScout 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.

HealthScout 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.

HealthScout 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

A Phase III Study of Consolidative Radiotherapy in Patients With Oligometastatic HER2 Negative Esophageal and Gastric Adenocarcinoma (EGA)

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.

HealthScout AI summary: Adults with HER2‑negative esophageal or gastric adenocarcinoma with oligometastatic disease (≤3 sites, no peritoneal/CNS) and at least stable disease after induction FOLFOX or CAPOX are randomized to consolidative radiotherapy to all known sites plus continuation of the same chemotherapy versus chemotherapy alone. Aims to determine if adding local radiotherapy improves overall survival; no investigational drugs are used.

ClinicalTrials.gov ID: NCT04248452

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.

HealthScout 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.

HealthScout 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.

HealthScout 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.

HealthScout 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 2 Study of Acalabrutinib in Combination With Lisocabtagene Maraleucel in Relapsed/Refractory Aggressive B-cell Lymphomas

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.

HealthScout AI summary: Adults with relapsed/refractory aggressive B‑cell lymphomas (e.g., de novo/transformed DLBCL, PMBCL, HGBCL including double/triple hit, and grade 3B FL) after ≥2 prior regimens receive standard lymphodepletion followed by lisocabtagene maraleucel (CD19-directed CAR T) plus oral acalabrutinib, a selective covalent BTK inhibitor. Secondary CNS involvement permitted; key exclusions include prior adoptive T-cell therapy, recent allo-HSCT/active GVHD, active hepatitis/HIV, and contraindications to acalabrutinib.

ClinicalTrials.gov ID: NCT05583149