Clinical Trials for Stomach Cancer

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

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 Phase 1 Study of TJ033721 in Subjects with Advanced or Metastatic Solid Tumors

TrialFetch AI summary: Adults with advanced/metastatic solid tumors (dose-escalation monotherapy) or treatment‑naïve, CLDN18.2‑positive gastric/GEJ/esophageal adenocarcinoma (combination cohorts) receive givastomig (TJ033721/ABL111), a CLDN18.2 × 4‑1BB bispecific antibody that conditionally activates 4‑1BB on T cells, either alone or with nivolumab plus chemotherapy. Key requirements include ECOG 0–1, known PD‑L1 CPS, CLDN18.2 positivity for expansion/combination, and no prior CLDN18.2 therapy or prior PD‑1/PD‑L1 therapy in the combination setting.

ClinicalTrials.gov ID: NCT04900818

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

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 II/III Trial of 2nd Line Nivolumab + Paclitaxel + Ramucirumab Versus Paclitaxel + Ramucirumab in Patients With PD-L1 CPS >/= 1 Advanced Gastric and Esophageal Adenocarcinoma (PARAMUNE)

TrialFetch AI summary: Adults with unresectable/metastatic, HER2‑negative, microsatellite‑stable gastric/GEJ/esophageal adenocarcinoma with PD‑L1 CPS ≥1 after exactly one prior PD‑1/PD‑L1–chemotherapy regimen are randomized to paclitaxel plus ramucirumab with or without nivolumab. Nivolumab is a PD‑1–blocking antibody; ramucirumab is a VEGFR2 antagonist, and paclitaxel is a microtubule stabilizer.

ClinicalTrials.gov ID: NCT06203600

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

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

A Phase 1B, Multicenter, Open-Label Study of the Safety and Efficacy of CHS-114 in Combination With Toripalimab With or Without Other Treatments in Participants With Advanced or Metastatic Solid Tumors

TrialFetch AI summary: Adults with unresectable, advanced/metastatic gastric/GEJ/esophageal adenocarcinoma (HER2‑negative, MSS/pMMR) in the 2L setting and ESCC in 1L or 2L receive the anti‑CCR8 monoclonal antibody CHS‑114 (depletes intratumoral CCR8+ Tregs via enhanced ADCC/ADCP) plus the PD‑1 inhibitor toripalimab, with cisplatin/5‑FU added in 1L ESCC. Requires measurable disease and tissue; excludes active CNS metastases and prior anti‑CCR8.

ClinicalTrials.gov ID: NCT06657144

A Phase II Study of sFOLFOXIRI in Advanced Gastroesophageal Cancer (SAGE)

TrialFetch AI summary: Adults with metastatic or unresectable HER2‑negative adenocarcinoma of the esophagus/GEJ/stomach (no prior metastatic therapy; ECOG 0–2) receive an alternating doublet sFOLFOXIRI schedule: mFOLFOX6 on odd cycles and FOLFIRI on even cycles every 2 weeks. Optional nivolumab (PD‑1 inhibitor) may be added per label to enhance antitumor activity.

ClinicalTrials.gov ID: NCT05332002

Phase I Trial of CA-4948 in Combination With FOLFOX/PD-1 Inhibitor +/- Trastuzumab for Untreated Unresectable Gastric and Esophageal Cancer

TrialFetch AI summary: First-line treatment for adults with unresectable/metastatic gastric, GEJ, or esophageal adenocarcinoma or squamous cell carcinoma (ECOG 0–1), testing oral IRAK4 inhibitor emavusertib (CA‑4948; targets TLR/IL‑1R→NF‑κB signaling, with FLT3/CLK activity) added to mFOLFOX7 plus PD‑1 blockade. HER2‑negative patients receive emavusertib + mFOLFOX7 + nivolumab; HER2‑positive patients receive emavusertib + mFOLFOX7 + pembrolizumab + trastuzumab.

ClinicalTrials.gov ID: NCT05187182

A Phase II Study of agenT-797 (Invariant Natural Killer T Cells), Botensilimab, a Novel Fc-enhanced CTLA-4 Inhibitor, Plus Balstilimab (Anti-PD-1) With Ramucirumab and Paclitaxel for Patients With Previously Treated, Advanced Esophageal, Gastric, or Gastro-esophageal Junction Adenocarcinoma

TrialFetch AI summary: Adults with unresectable/metastatic esophageal, gastric, or GEJ adenocarcinoma after one prior line (or relapse ≤6 months after perioperative therapy), ECOG 0–1, receive ramucirumab plus paclitaxel combined with investigational immunotherapies: agenT‑797 (allogeneic invariant NKT cell therapy targeting CD1d-presented glycolipids), botensilimab (Fc‑enhanced CTLA‑4 inhibitor), and balstilimab (PD‑1 inhibitor). Excludes prior ramucirumab, recent taxane, severe prior irAEs from PD‑(L)1/CTLA‑4, active CNS mets, significant neuropathy, or active viral infections.

ClinicalTrials.gov ID: NCT06251973

A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants With HER2-expressing Gastric Cancer (DESTINY-Gastric-03)

TrialFetch AI summary: Adults with unresectable/metastatic HER2-expressing gastric/GEJ/esophageal adenocarcinoma (HER2-positive or HER2-low) receive trastuzumab deruxtecan (anti‑HER2 antibody–drug conjugate delivering a topoisomerase I inhibitor) as monotherapy or combined with fluoropyrimidines and/or checkpoint inhibitors (durvalumab, pembrolizumab, or investigational bispecifics volrustomig [PD‑1/CTLA‑4] and rilvegostomig [PD‑1/TIGIT]); first-line cohorts include a comparator of trastuzumab plus fluoropyrimidine/platinum. Prior trastuzumab exposure is required only for a post-trastuzumab cohort, with key exclusions including active ILD/pneumonitis and untreated CNS metastases.

ClinicalTrials.gov ID: NCT04379596