Clinical Trials for Stomach Cancer

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)

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.

HealthScout 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

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.

HealthScout 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

An Open-Label, International, Multicenter, Phase 1b/2a Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination with XELOX (Capecitabine and Oxaliplatin) or Irinotecan in Patients with Advanced Gastric Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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 or metastatic gastric or gastroesophageal junction cancer receive the PARP1/2 inhibitor venadaparib (IDX-1197) combined with XELOX in first-line HER2-negative disease or with irinotecan in later lines (with UGT1A1 genotyping in one part), to define safe dosing and assess preliminary activity. Suitable for ECOG 0–1 patients without uncontrolled CNS disease or significant comorbidities; exploratory interest includes potential benefit in HRD-mutated subsets.

ClinicalTrials.gov ID: NCT04725994

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.

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 Multicenter, Randomized, Open-Label, Phase 3 Trial of Trastuzumab Deruxtecan (Enhertu®) Plus Chemotherapy Plus or Minus Pembrolizumab Versus Chemotherapy Plus Trastuzumab Plus or Minus Pembrolizumab as First-Line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Gastric Or Gastroesophageal Junction (GEJ) Cancer (Destiny-Gastric05)

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.

HealthScout AI summary: First-line trial in adults with unresectable/metastatic, centrally confirmed HER2-positive gastric/GEJ adenocarcinoma (main cohort PD-L1 CPS ≥1; exploratory CPS <1) comparing trastuzumab deruxtecan (HER2-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor) plus a fluoropyrimidine ± pembrolizumab versus standard trastuzumab plus platinum/fluoropyrimidine chemotherapy ± pembrolizumab. Key exclusions include prior HER2 therapy, significant cardiac/pulmonary disease, and history of ILD/pneumonitis.

ClinicalTrials.gov ID: NCT06731478

Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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 relapsed/refractory CD19-positive B‑cell malignancies (DLBCL/high‑grade B‑cell lymphoma, transformed/Richter, B‑ALL/B‑LBL, or CML in lymphoid blast crisis) receive targeted conditioning with 131‑I apamistamab (anti‑CD45 radiolabeled mAb delivering marrow/lymphoid radiation) followed by 19‑28z CD19‑directed CAR T cells. Prior CD19 therapies (including CAR T) are allowed with confirmed CD19 expression; key exclusions include uncontrolled infection, significant cardiac disease, active GVHD/autoimmune disease requiring systemic T‑cell suppression, and inadequate organ function.

ClinicalTrials.gov ID: NCT04512716

Adaptive Radiation for Abdominopelvic Metastases (ARAM)

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.

HealthScout AI summary: Adults with metastatic solid tumors limited to abdominopelvic lesions (ECOG 0–1, no prior RT to target, ≤5 active metastases) receive adaptive stereotactic body radiation therapy with daily online plan adaptation, using dose-escalated SBRT (8–10 Gy/fx) to optimize target coverage while monitoring for grade ≥3 toxicity. Single-arm dose-escalation study; excludes peritoneal carcinomatosis and active extra-abdominopelvic disease.

ClinicalTrials.gov ID: NCT05880667

Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction

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.

HealthScout AI summary: Adults with symptomatic malignant gastric outlet obstruction from distal gastric or duodenal tumors, suitable for surgical bypass and general anesthesia, are randomized to laparoscopic Roux-en-Y gastric bypass versus standard loop gastrojejunostomy for palliative restoration of oral intake. The trial compares postoperative gastric emptying and diet tolerance, along with complications, reoperation, short-term survival, and quality of life.

ClinicalTrials.gov ID: NCT05986890

A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination With Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors Are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-Positive

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.

HealthScout AI summary: Adults with unresectable or metastatic gastric/GEJ adenocarcinoma that is HER2-negative, CLDN18.2-positive, and PD-L1–positive (ECOG 0–1) are randomized to pembrolizumab plus CAPOX or mFOLFOX6 with either zolbetuximab or placebo. Zolbetuximab is a CLDN18.2-targeted IgG1 monoclonal antibody that mediates ADCC/CDC; key exclusions include prior metastatic-line therapy (beyond one initial dose), active autoimmune disease, immune pneumonitis, CNS mets, significant GI obstruction/bleeding, and >grade 1 neuropathy.

ClinicalTrials.gov ID: NCT06901531

A Phase III Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients Newly Diagnosed With Grade 1 and Grade 2 (Ki-67 <10%) Advanced GEP-NET With High Disease Burden (NETTER-3)

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.

HealthScout AI summary: Newly diagnosed, unresectable/metastatic, SSTR-positive, well-differentiated G1–G2 (Ki-67 &lt;10%) advanced GEP-NETs with high disease burden (adolescents/adults, ECOG 0–1) randomized to [177Lu]Lu-DOTA-TATE plus octreotide LAR versus octreotide LAR alone. [177Lu]Lu-DOTA-TATE is a somatostatin receptor–targeted peptide receptor radionuclide therapy delivering beta-emitting 177Lu via DOTA-TATE to SSTR2-expressing tumors.

ClinicalTrials.gov ID: NCT06784752