Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-30 @ 4:28 PM
Study NCT ID:
NCT07053332
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-08
First Post:
2025-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on Immunotherapy Combined With Radiotherapy for Esophagogastric Junction/Gastric Adenocarcinoma
Sponsor:
Jiangsu Cancer Institute & Hospital
Organization:
Study Overview
Official Title:
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.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
This study is a prospective, single-center, single-arm Phase II clinical trial. Participants will be patients with resectable locally advanced dMMR/MSI-H esophagogastric junction/gastric adenocarcinoma staged as cT1-2N1-3M0 or T3-T4aN0-3M0 according to the AJCC/UICC staging system. The objective of this study is to evaluate the safety and efficacy of PD-1/CTLA-4 combination antibody therapy combined with low-dose radiotherapy in patients with locally advanced resectable dMMR/MSI-H esophagogastric junction/gastric adenocarcinoma.
Eligible participants who meet the inclusion criteria will be enrolled in the study.
Primary endpoint: Pathological complete response rate (pCR), defined as pT0N0M0，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..
Secondary endpoints:
Treatment feasibility: the proportion of patients who complete neoadjuvant therapy and undergo surgery within 3-5 weeks after treatment.
Major pathological response rate (MPR): the percentage of residual viable tumor cells in the tumor bed after neoadjuvant therapy ≤10%.
Imaging-assessed response rate: evaluated using multimodal imaging including CT/GI ultrasound and MRI.
R0 resection rate: the proportion of patients achieving R0 resection among all enrolled patients.
Treatment safety: recorded using CTCAE 5.0 for grade 3 or higher treatment-related adverse events, from the start of neoadjuvant therapy until 30 days after surgery.
Postoperative complications: assessed using the Clavien-Dindo classification. Time to recurrence (TTR): time from the start of the study to the first documented recurrence.
Progression-free survival (PFS): time from the start of the study to tumor progression (in any aspect) or death from any cause.
Overall survival (OS): time from the start of the study to death from any cause.
Treatment schedule:
The maximum interval between participant screening and initiation of treatment is 3 weeks (≤21 days).
PD-1/CTLA-4 combination antibody: Eparaplimab Icotinib Injection, 5 mg/kg on Day 1, Day 22, and Day 43, administered intravenously, for a total of three cycles.
Radiotherapy: Initiated within one week of starting immunotherapy, total dose DT: 30 Gy, 2.5 Gy × 12 fractions, once daily, five times per week.
Surgery: Performed 3-5 weeks after completion of neoadjuvant therapy. Postoperative adjuvant therapy: Eparaplimab Icotinib Injection, 5 mg/kg on Day 1, every 3 weeks (Q3W), administered intravenously, continued up to 1 year.
The study continues until disease progression, voluntary withdrawal by the patient, or occurrence of intolerable toxicities. Efficacy and safety assessments are conducted every two cycles (42 days ±7 days). If disease progression is observed (based on investigator evaluation or imaging evidence), the patient will voluntarily withdraw from the study; if intolerable toxicities occur, the participant should discontinue study treatment. In the event of treatment discontinuation for any reason, a final study visit should be conducted approximately 12 weeks after the last dose of study drug, to collect all possible adverse events and concomitant medication information. Follow-up of drug-related or possibly related adverse events should continue until the event stabilizes or resolves.
A notice of study completion will be submitted to the hospital's Clinical Trial Management Center based on the date of the final follow-up visit of the last enrolled participant. An update and status annotation will also be made at the clinical trial registry.
Eligible participants who meet the inclusion criteria will be enrolled in the study.
Primary endpoint: Pathological complete response rate (pCR), defined as pT0N0M0，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..
Secondary endpoints:
Treatment feasibility: the proportion of patients who complete neoadjuvant therapy and undergo surgery within 3-5 weeks after treatment.
Major pathological response rate (MPR): the percentage of residual viable tumor cells in the tumor bed after neoadjuvant therapy ≤10%.
Imaging-assessed response rate: evaluated using multimodal imaging including CT/GI ultrasound and MRI.
R0 resection rate: the proportion of patients achieving R0 resection among all enrolled patients.
Treatment safety: recorded using CTCAE 5.0 for grade 3 or higher treatment-related adverse events, from the start of neoadjuvant therapy until 30 days after surgery.
Postoperative complications: assessed using the Clavien-Dindo classification. Time to recurrence (TTR): time from the start of the study to the first documented recurrence.
Progression-free survival (PFS): time from the start of the study to tumor progression (in any aspect) or death from any cause.
Overall survival (OS): time from the start of the study to death from any cause.
Treatment schedule:
The maximum interval between participant screening and initiation of treatment is 3 weeks (≤21 days).
PD-1/CTLA-4 combination antibody: Eparaplimab Icotinib Injection, 5 mg/kg on Day 1, Day 22, and Day 43, administered intravenously, for a total of three cycles.
Radiotherapy: Initiated within one week of starting immunotherapy, total dose DT: 30 Gy, 2.5 Gy × 12 fractions, once daily, five times per week.
Surgery: Performed 3-5 weeks after completion of neoadjuvant therapy. Postoperative adjuvant therapy: Eparaplimab Icotinib Injection, 5 mg/kg on Day 1, every 3 weeks (Q3W), administered intravenously, continued up to 1 year.
The study continues until disease progression, voluntary withdrawal by the patient, or occurrence of intolerable toxicities. Efficacy and safety assessments are conducted every two cycles (42 days ±7 days). If disease progression is observed (based on investigator evaluation or imaging evidence), the patient will voluntarily withdraw from the study; if intolerable toxicities occur, the participant should discontinue study treatment. In the event of treatment discontinuation for any reason, a final study visit should be conducted approximately 12 weeks after the last dose of study drug, to collect all possible adverse events and concomitant medication information. Follow-up of drug-related or possibly related adverse events should continue until the event stabilizes or resolves.
A notice of study completion will be submitted to the hospital's Clinical Trial Management Center based on the date of the final follow-up visit of the last enrolled participant. An update and status annotation will also be made at the clinical trial registry.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: