RecruitingPhase 2NCT06765616

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

Adebrelimab Injection (PD-L1) Combined With Short Course Radiotherapy and Chemotherapy for Neoadjuvant Therapy of Locally Advanced Rectal Cancer: a Multicenter, Single Arm Prospective Study

Sponsor

Feng Tian

Enrollment

31 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Rectal Cancer Radiotherapy Advanced Stage Colorectal Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding an immunotherapy drug (adebrelimab, a PD-L1 blocker) to short-course radiation and chemotherapy before rectal cancer surgery leads to better outcomes than current standard care. It is aimed at patients with locally advanced rectal cancer. **You may be eligible if...** - You have been diagnosed with rectal adenocarcinoma (a type of rectal cancer confirmed by biopsy) - Your tumor is locally advanced (stage T3 or higher, or has spread to nearby lymph nodes) but has not spread to distant organs - Your tumor is located within 15 cm of the anus - You are between 18 and 85 years old and have not received prior treatment for this cancer - You are healthy enough to undergo surgery after neoadjuvant therapy - Your major organ function (heart, liver, kidneys) is adequate **You may NOT be eligible if...** - You have already received chemotherapy or radiation for this cancer - You have another active cancer - You have a serious heart or immune condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdebrelimab 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.