Not Yet RecruitingPhase 2

A Study on Immunotherapy Combined With Radiotherapy for Esophagogastric Junction/Gastric Adenocarcinoma

20 participantsStarted 2025-07

Plain-language summary

A single-arm, prospective phase II clinical study of neoadjuvant PD-1/CTLA-4 combination antibody with low-dose radiotherapy in resectable dMMR/MSI-H esophagogastric junction/gastric adenocarcinoma.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Patients voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and agree to follow-up;
✓. Patients with esophagogastric junction/gastric adenocarcinoma (Siewert type II/III) confirmed by endoscopic pathology (note: pathologies from other hospitals must be reviewed at our hospital), with dMMR/MSI-H status confirmed by immunohistochemistry or genetic testing;
✓. Based on endoscopic, CT, MRI, or PET-CT findings, AJCC 8th edition staging is cT1-2N1-3M0 or T3-T4aN0-3M0;
✓. Age between 18 and 80 years, inclusive of both 18 and 80, both genders are eligible;
✓. ECOG PS score of 0-1;
✓. Presence of measurable and/or non-measurable lesions as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1);
✓. No prior systemic anti-tumor treatment (including but not limited to systemic chemotherapy, radiotherapy, molecular targeted therapy, immunotherapy, biologic therapy, local therapy, or investigational drugs);
✓. The function of major organs must meet the following criteria (no blood components or cell growth factors allowed within 2 weeks before screening):

Exclusion criteria

✕. History of surgery for gastric or gastroesophageal junction tumor;
✕. Immunohistochemistry or genetic testing shows pMMR, MSI-L, or MSS;
✕. High risk of gastrointestinal bleeding or perforation;
✕. Poor nutritional status, BMI \< 18.5 kg/m², or PG-SGA score ≥ 9;
✕. Major surgery or serious trauma within 4 weeks prior to the first use of the study drug;
✕. Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
✕. Previously received or is currently receiving any of the following treatments: anti-PD-1 or anti-PD-L1 antibody therapy, chemotherapy, radiotherapy, targeted therapy;
✕. Received any investigational drug within 4 weeks prior to the first use of the study drug;

What they're measuring

Pathological complete response rate (pCR)

Timeframe: Assessed average of 1 month after surgery

Safety

Timeframe: From the start of treatment until 30 days after surgery

Trial details

NCT IDNCT07053332

SponsorJiangsu Cancer Institute & Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Cao Yue

13645160518 yuechaomeng@126.com

View on ClinicalTrials.gov More Esophagogastric Junction/Gastric Adenocarcinoma trials