Not Yet RecruitingPhase 2

Short-Course Radiotherapy Combined With Chemotherapy and Immunotherapy in Mid-Low Locally Advanced Rectal Cancer

China19 participantsStarted 2026-03-01

Plain-language summary

The goal of this clinical trial is to test a new combination treatment for locally advanced rectal cancer (cancer in the lower or middle part of the rectum that has not spread to distant organs). The study aims to increase the chance of making the tumor disappear completely (called "complete response") and improve the quality of life by increasing the rate of anal sphincter preservation (avoiding permanent colostomy bags). The main questions it aims to answer are: Does the combination of short-course radiation therapy, two types of immunotherapy drugs (Qibeian and Aike), and chemotherapy (XELOX) increase the complete response rate to over 50%? Is this combination treatment safe, and what are the side effects? Can this treatment help more patients keep their anal function and avoid permanent stomas? This is a single-arm study, meaning all participants will receive the experimental treatment (there is no placebo or control group). Participants will: Receive short-course radiation therapy (25 Gy total, given once daily for 5 consecutive days). The radiation will target only the tumor and visible lymph nodes, intentionally avoiding unaffected lymph node areas to protect the immune system. Receive Qibei'an (a dual immunotherapy drug targeting both PD-1 and CTLA-4) once, 2 days after completing radiation. Receive Camrelizumab (a PD-1 immunotherapy drug) three times, combined with XELOX chemotherapy. Receive XELOX chemotherapy (Oxaliplatin ivgtt on Day 1, plus Capecitabine pills taken twice daily for 14 days, for each cycle) for up to 3 cycles. Undergo detailed assessments after treatment, including MRI scans, colonoscopy with biopsies, and blood tests (including ctDNA tests), to determine if the tumor has disappeared or if surgery is needed. Attend regular follow-up visits for up to 5 years after treatment (or surgery) to monitor for recurrence and assess quality of life. The study will enroll approximately 19 patients at Beijing Friendship Hospital, Capital Medical University. An independent safety monitoring board will regularly review the data to ensure participant safety.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Age 18-75 years.
✓. ECOG performance status score 0-2.
✓. Rectal adenocarcinoma confirmed by colonoscopic pathology, with pMMR or MSS.
✓. Imaging studies confirm no distant metastasis or lateral lymph node metastasis; MRI staging is II/III (excluding T4b, N1c, N2) and any positive lymph nodes (if present) are confined within the mesorectum.
✓. MRI shows the distal margin of the tumor is ≤10 cm from the anal verge, and the mesorectal fascia (MRF) is negative.
✓. The longest diameter of the rectal cancer lesion is ≥10 mm on baseline CT or MRI (meeting the definition of a "measurable lesion" per RECIST 1.1 criteria).
✓. Willing and able to comply with the study procedures.
✓. Consent to the use of tissue and blood samples by the investigator for medical research purposes.

Exclusion criteria

✕. Multifocal cancer, or concomitant other malignant tumors.

What they're measuring

Complete response rate

Timeframe: Approximately 4 months after treatment starts

Trial details

NCT IDNCT07397442

SponsorBeijing Friendship Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Yingchi Yang, M.D.

+86 15810152032 yangyingchi@ccmu.edu.cn

View on ClinicalTrials.gov More Rectal Cancer, Adenocarcinoma trials