A Study on Immunotherapy Combined With Radiotherapy for Esophagogastric Junction/Gastric Adenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJiangsu Cancer Institute & Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
PD-1/CTLA-4 combination antibody with low-dose radiotherapy
Drug* PD-1/CTLA-4 combination antibody: Iparomlimab and Tuvonralimab， 5mg/kg on day 1, day 22, and day 43, administered via intravenous infusion, for a total of three cycles before surgery and maintained for up to 1 year after surgery. * Radiotherapy: To be conducted within one week of the start of immunotherapy, with a total dose of DT: 30Gy, 2.5Gy × 12 fractions, once daily, five times per week. The preoperative radiotherapy target area will be delineated by the radiation oncologist in accordance with the "NCCN Guidelines for Gastric/Esophagogastric Junction Cancers 2022" and in consultation with the opinions of the general surgeon. * Surgery: Surgical treatment will be completed within 3-5 weeks after the completion of neoadjuvant therapy. * Adjuvant therapy: Postoperative immunotherapy will be maintained for up to 1 year.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: PD-1/CTLA-4 combination antibody with low-dose radiotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pathological complete response rate (pCR)
Pathological complete response is defined as pT0N0M0.
Time frame
Assessed average of 1 month after surgery2
Safety
Treatment-related adverse reactions of grade 3 or above according to CTCAE 5.0 will be recorded from the start of treatment until 30 days after surgery.
Time frame
From the start of treatment until 30 days after surgerySecondary outcomes
1
Major pathological response rate (Major pathological response, MPR)
After neoadjuvant therapy, the percentage of residual viable tumor cells within the tumor bed is ≤10%.
Time frame
Assessed average of 1 month after surgery2
R0 resection rate (Complete Resection With no Tumor Within 1 mm of the Resection Margins (R0) Rate)
The proportion of patients who achieve R0 resection among all enrolled patients.
Time frame
Assessed average of 1 month after surgery3
Post-operative complications
Assessed using the Clavien-Dindo classification
Time frame
Assessed average of 1 month after surgery4
Time to relapse (Time to Relapse, TTR)
The time from the start of the study to the first documented relapse.
Time frame
From the time of enrollment, until the disease relapses or metastasizes，assessed up to 5 years follow-up.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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