Neoadjuvant chemoradiotherapy with or without tislelizumab for ultra-low rectal cancer – RELIEVE-02

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 Phase 3, open-label, multicenter trial enrolls adults with newly diagnosed, resectable ultra-low rectal adenocarcinoma. Participants are randomized to receive long-course chemoradiotherapy with or without tislelizumab, followed by three to six cycles of CAPOX chemotherapy with or without tislelizumab. Those achieving complete or near-complete clinical response may continue with additional chemotherapy and a watch-and-wait approach, while incomplete responders proceed to total mesorectal excision. Primary endpoint is anus preservation rate, with secondary endpoints including complete response rates, organ preservation, event-free survival, and overall survival over several years. The lead sponsor is Fudan University, with the study conducted at Zhongshan Hospital, Shanghai.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Able to provide written informed consent, understand, and comply with the requirements and evaluation schedule.
2. Age ≥18 and ≤75 years old.
3. Histologically confirmed rectal adenocarcinoma.
4. Immunohistochemistry confirmed pMMR (positive for MLH1, MSH2, MSH6, and PMS2), or PCR/NGS confirmed MSI-L or MSS.
5. Tumor distal margin confirmed to be ≤ 3 cm from the anal verge by colonoscopy, digital rectal examination, or MRI.
6. Clinical stage cT1-3N1M0 or cT3N0M0 (the 8th UICC/AJCC; T and N evaluated by MRI).
7. Resectable primary tumor assessed by the Investigator.
8. No prior anti-tumor treatment for rectal cancer.
9. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1.
10. Adequate organ function.
11. Female subjects with the ability to become pregnant must have a serum pregnancy test with a negative result within 72 hours before the first dose and be willing to use highly effective contraceptive methods during the trial and for 120 days after the last dose. Male subjects whose partners are women of childbearing potential should be surgically sterilized or agree to use a highly effective method of contraception during the trial and for 120 days after the last dose.

Exclusion Criteria:

1. Histologically confirmed poorly differentiated/undifferentiated adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma.
2. Previously received treatment for rectal cancer or have evidence of distant metastasis.
3. Presence of the following high-risk factors assessed by MRI: MRF+, EMVI+, cN2, positive lateral lymph nodes, T3d.
4. Presence of or at high risk for obstruction, perforation, or bleeding.
5. Unsuitability for long-course radiotherapy.
6. Inability to tolerate surgery.
7. ≥ 2 colorectal cancer lesions at the same time.
8. Contraindications for MRI examination.
9. Other malignant tumors in the past or currently present.
10. Active autoimmune disease requiring systemic therapy within the past 2 years.
11. HIV infection.
12. Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA \> 500 IU/mL) or active HCV carriers with detectable HCV RNA.
13. Hypersensitivity to any ingredient of tislelizumab, capecitabine, and oxaliplatin, or to any component of their containers.
14. Other conditions judged by the researcher as not meeting the enrollment requirements.

Where it's running

• Zhongshan Hospital, Fudan University
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Jianmin Xu, MD
• Email: xujmin@aliyun.com
• Phone: 86-21-64041990

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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.