Node-sparing short-course radiation with capecitabine plus PD-1/CTLA-4 immunotherapy for early rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm Phase 2 study delivers short-course, lymph-node-sparing radiotherapy (25 Gy in 5 fractions) to the primary tumor, immediately followed by four 3-week cycles of capecitabine combined with a PD-1 plus CTLA-4 inhibitor (Aiparolitoworixureli). Two weeks after completing chemo-immunotherapy, tumor response is assessed and patients with a clinical complete response may enter a watch-and-wait program while others proceed to local excision or total mesorectal excision as clinically indicated. The primary endpoint is complete response rate (clinical and pathological), and secondary endpoints include organ-preservation rate, 3-year local recurrence, 3-year disease-free and overall survival, toxicity, and quality-of-life. The trial enrolls treatment-naïve adults aged 18–80 with low (≤7 cm from the anal verge) cT2–3N0M0 MSS/pMMR rectal adenocarcinoma and ECOG 0–1 at Sir Run Run Shaw Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients who have a strong willingness to preserve the anus and are willing to receive neoadjuvant therapy.
2. Male or Female aged 18-80.
3. Patients diagnosed with low rectal cancer within 7 cm from the lower edge of the tumor to the anal verge by pelvic MRI and rectal ultrasound, the clinical stage is cT2-3N0M0.
4. Histologically confirmed rectal adenocarcinoma; Genetic testing suggests MSI-L or MSS, or tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive.
5. Eastern Cooperative Oncology Group (ECOG) score 0-1.
6. No previous treatment (including anti-tumor therapy, immunotherapy or pelvic radiation).
7. Informed consent form signed.

Exclusion Criteria:

1. Patients with a previous history of malignant tumors besides rectal cancer.
2. Patients with distant metastases before enrollment.
3. Patients with metastatic regional or non-regional lymph nodes are assessed by MRI or CT.
4. Patients with obstruction, perforation, or bleeding that require emergency surgery.
5. Patients with severe concomitant diseases and estimated survival time ≤ 5 years.
6. Allergic to any component of the therapy.
7. Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of therapy.
8. Contraindications to radiotherapy and chemotherapy.
9. Patients who have received any other experimental drug (including immunotherapy) or participated in another interventional clinical trial within 30 days before screening.
10. Factors leading to study termination, such as alcoholism, drug abuse, other serious illnesses (including psychiatric disorders) requiring combination therapy, and patients with severe laboratory abnormalities. Patients with congenital or acquired immune deficiency (such as HIV infection).
11. Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, pregnant or lactating women, illiterate, etc.

    Other conditions that investigators consider not suitable for this study.
12. Patient not suitable for participating by other concerns of researchers.

Where it's running

• Sir run run shaw hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Bingjun Bai, MD
• Email: echobai@zju.edu.cn
• Phone: 8613858816897

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.