RecruitingPhase 2NCT06542588

Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07and Serplulimab in LARC

A Multicenter, Single-arm, Open-label Clinical Trial of Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07 and Serplulimab in the Treatment for RAS/BRAF Wild Type Locally Advanced Rectal Cancer


Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Enrollment

29 participants

Start Date

Jul 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The study is a multicenter, open-label, phase II clinical study, and the purpose of the study is to explore the complete response rate (CR, Defined as pathological complete response (pCR) + Clinical complete response (cCR)) of patients with RAS/BRAF wild type locally advanced rectal cancer(LARC) treated with short-term radiotherapy, sequential HLX07, Serplulimab and CAPOX. A total of 29 patients were included in this study.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination treatment approach for locally advanced rectal cancer — a type of colon cancer near the rectum that hasn't spread to distant organs but is in an advanced local stage. The approach combines short-course radiation, followed by chemotherapy, a targeted antibody drug (HLX07), and an immunotherapy (serplulimab), all before surgery. The goal is to shrink the tumor as much as possible before the operation. **You may be eligible if...** - You are 18–75 years old with locally advanced rectal adenocarcinoma confirmed by biopsy - Your tumor is located within 10 cm of the anal opening - Genetic testing confirms your tumor has wild-type RAS and BRAF genes (not mutated) - MRI shows high-risk features such as tumor growing through the bowel wall or into neighboring structures **You may NOT be eligible if...** - Your cancer has spread to distant organs (e.g., liver, lungs) - Your tumor has RAS or BRAF mutations - You have active autoimmune disease or a condition requiring systemic steroids - You are pregnant or breastfeeding 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

COMBINATION_PRODUCTHLX07(anti EGFR antibody) and Serplulimab(anti PD-1 antibody)

Short course radiotherapy sequential HLX07, Serplulimab and chemotherapy


Locations(3)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Hubei, China

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NCT06542588


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