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Adebrelimab Injection (PD-L1) Combined With Short Course Radiotherapy and Chemotherapy for Neoadjuvant Therapy of Locally Advanced Rectal Cancer

NCT06765616 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-01-09

No results posted yet for this study

Summary

This study is a multicenter, single arm, prospective study aimed at evaluating the efficacy and safety of adebelimab combined with short course radiotherapy (5 \* 5Gy) and chemotherapy as preoperative neoadjuvant therapy for locally advanced rectal cancer patients. In the study, all subjects who met the inclusion criteria will receive a combination of adebelimab, short course radiotherapy (5 \* 5Gy), and CAPOX chemotherapy as neoadjuvant therapy according to the study plan. TME surgery will be performed 2-3 weeks after the last dose of neoadjuvant therapy. If the surgery cannot be performed within the time window specified in the protocol (such as delayed adverse reactions, etc.), the researcher will consider the actual clinical situation of the subjects comprehensively.

Conditions

Interventions

DRUG

Adebrelimab Injection combined with radiotherapy and chemotherapy

Radiotherapy regimen: SCRT short-term radiotherapy of 5 × 5Gy Immunotherapy regimen: Adebrelimab Injection 1200 mg or 20 mg/kg, iv., followed by administration on the 1st day of each subsequent chemotherapy cycle. Chemotherapy regimen: CAPOX regimen (chemotherapy cycle d1, to chemotherapy cycle d14): Oxaliplatin 130 mg/m2 iv d1 Capecitabine 1000 mg/m2 po bid d1\~14 Repeat every 3 weeks for 6 cycles After completing 6 cycles of chemotherapy, the patient underwent TME surgery 2-3 weeks later.

Sponsors & Collaborators

  • Feng Tian

    lead OTHER_GOV

Principal Investigators

  • Changqing Jing, Professor · Shandong Provincial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-07-01
Completion
2026-07-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06765616 on ClinicalTrials.gov