Clinical Trials for Esophageal 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.

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

Patient Preference for Subcutaneous vs. Intravenous Immune Therapy (PSI-Immune)

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.

TrialFetch AI summary: Adults with locally advanced or metastatic solid tumors eligible for on-label PD-1 therapy (nivolumab or pembrolizumab) are randomized in a crossover design to receive standard PD-1 inhibitors via subcutaneous versus intravenous administration, assessing patient/clinician preference, satisfaction, QoL, safety, and selected clinical outcomes. Includes PD-(L)1–naïve patients or those willing to switch; excludes prior severe hypersensitivity and transplant history.

ClinicalTrials.gov ID: NCT07223424

An Open-label Phase 1/2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients with Select Solid Tumors.

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

TrialFetch AI summary: This clinical trial evaluates the safety and efficacy of the investigational drug NEO212, a novel conjugate of temozolomide and perillyl alcohol with enhanced brain penetration, in adults with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype, or uncontrolled brain metastases from select solid tumors, including combinations with standard treatments like pembrolizumab or ipilimumab.

ClinicalTrials.gov ID: NCT06047379

Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) Alone or in Combination With Other Agents for the Treatment of Patients With Advanced HER2+ Metastatic Breast Cancer (mBC) and Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (mGEAC)

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: This trial enrolls adults with HER2-positive metastatic breast, gastric, gastroesophageal junction, or esophageal adenocarcinoma who have progressed after standard therapy, testing the selective HER2 tyrosine kinase inhibitor zongertinib (BI 1810631) alone or in combination with HER2-targeted agents (T-DXd, T-DM1, trastuzumab, capecitabine). Eligible patients must have measurable disease and good performance status (ECOG 0-1).

ClinicalTrials.gov ID: NCT06324357

Phase 1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRAS G12C Mutant Solid Tumors

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: This trial enrolls adults with advanced or metastatic solid tumors harboring KRAS G12C mutations (including pretreated NSCLC and other solid tumors), who receive a combination of the investigational KRAS G12C inhibitors RMC-6291 and RMC-6236. Both agents specifically inhibit KRAS G12C mutant protein to suppress tumor growth, and eligibility includes both KRAS G12C inhibitor–naïve and previously treated patients, excluding those with primary CNS tumors or active brain metastases.

ClinicalTrials.gov ID: NCT06128551

A Phase I Trial of Intraperitoneal Mesothelin-Targeted CAR T-Cell Therapy in Patients With Mesothelin-Positive Esophagogastric Adenocarcinoma With Peritoneal Carcinomatosis

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: Eligible patients are adults with metastatic or recurrent mesothelin-positive esophagogastric adenocarcinoma and peritoneal carcinomatosis who have progressed on prior systemic therapies. Participants receive intraperitoneal infusion of M28z1XXPD1DNR, an autologous CAR T-cell therapy targeting mesothelin with modifications to enhance activity and resist PD-1–mediated immune suppression.

ClinicalTrials.gov ID: NCT06623396

Phase II Study of Hypofractionated Radiation Therapy to Augment Immune Response in Patients With Metastatic GastroIntestinal Malignancies Progressing on Immune Therapy (ARM-GI)

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: This trial enrolls adults with metastatic gastrointestinal cancers (including esophageal, gastric, small intestine, hepatocellular, pancreaticobiliary, colorectal, or anal) who are progressing on a checkpoint or CTLA-4 inhibitor, treating them with hypofractionated external beam radiation (30 Gy in 5 fractions to 1-5 lesions) in addition to ongoing immunotherapy. The aim is to determine if radiation can enhance systemic immune response and improve outcomes in this refractory population.

ClinicalTrials.gov ID: NCT04221893

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.

TrialFetch 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

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