Clinical Trials for Esophageal Cancer

Sacituzumab Govitecan in Combination With Capecitabine for Advanced Gastrointestinal Cancers After Progression on Standard Therapy

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 metastatic GI adenocarcinomas (colorectal, pancreaticobiliary, or upper GI) progressing after standard therapy receive sacituzumab govitecan (Trop-2–targeted ADC delivering SN-38/topoisomerase I inhibitor) plus capecitabine in 21-day cycles; prior topo I inhibitor exposure is excluded, treated/stable brain mets allowed. Dose-escalation assesses safety/tolerability and seeks an RP2D, with exploratory correlation to tumor Trop-2 expression.

ClinicalTrials.gov ID: NCT06065371

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

Active drug

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

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.

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 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

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

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.

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

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

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