Short-Course Radiotherapy Followed by CAPOX With or Without Iparomlimab and Tuvonralimab in Localized 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 multicenter, randomized phase III trial compares short-course radiotherapy followed by CAPOX chemotherapy alone versus CAPOX plus iparomlimab and tuvonralimab in patients with pMMR/MSS locally advanced rectal adenocarcinoma. Eligible participants have stage II-III disease, a tumor within 12 cm of the anal verge, and high-risk features, with no distant metastasis. After total neoadjuvant therapy, responders may enter a Watch-and-Wait approach if clinically complete, while others proceed to total mesorectal excision per standard practice. The primary endpoint is the rate of complete response, defined by pathologic complete response after surgery or sustained clinical complete response for over one year; secondary endpoints include 3-year relapse-free survival and other outcomes related to disease control and safety.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients aged 18-75 years with histologically confirmed pMMR/MSS rectal adenocarcinoma are eligible if they have MRI-defined clinical stage II or III disease according to AJCC 8th edition, tumor located within 12 cm from the anal verge, and at least one high-risk feature, including cT4b, cN2, EMVI positivity, MRF positivity, lateral lymph node positivity, tumor deposits, or tumor located ≤5 cm from the anal verge. Patients must have no distant metastasis, ECOG performance status 0-1, life expectancy greater than 6 months, and adequate hematologic, hepatic, and renal function

Exclusion Criteria:

* active or prior autoimmune disease requiring systemic treatment, use of immunosuppressive therapy or systemic corticosteroids at immunosuppressive doses, severe hypersensitivity to monoclonal antibodies, uncontrolled cardiac disease, significant coagulopathy or bleeding tendency, active infection, interstitial lung disease or severe pulmonary dysfunction, HIV infection or active hepatitis, prior or concurrent malignancy except specified cured cancers, recent investigational drug use, planned use of other systemic antitumor therapy during the study, pregnancy or breastfeeding, and any other condition judged by the investigator to make participation unsuitable.

Where it's running

• Shandong Cancer Hospital and Institute
  Jinan, Shandong, China Recruiting

Study contacts

• Principal investigator: Jinbo Yue, Doctor — Study Principal Investigator
• Study coordinator: Jinbo Yue Doctor
• Email: jbyue@sdfmu.edu.cn
• Phone: 0531-67626442

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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.