Neoadjuvant treatment for locally advanced 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 phase II multicenter, randomized trial evaluates the safety and efficacy of neoadjuvant short-course radiotherapy combined with AK112, with or without chemotherapy, in patients with locally advanced rectal cancer. Participants will be randomly assigned to receive either short-course radiotherapy followed by chemotherapy and AK112 or short-course radiotherapy followed by AK112 alone. The study aims to assess treatment response rates, safety, and identify biomarkers that predict tumor response. A total of 100 participants will be enrolled across multiple centers over three years.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Signed written informed consent.
2. Age 18-80 years, male or female.
3. Histologically confirmed rectal adenocarcinoma.
4. Clinical baseline stage T3-4NxM0 or TxN1-2M0 by MRI assessment.
5. Able to swallow tablets.
6. ECOG Performance Status of 0-1.
7. No prior treatment for rectal cancer, including surgery, radiotherapy, 8.chemotherapy, immunotherapy, or targeted therapy.

9.Fit for surgery with no contraindications. 10.Normal organ function. 11.Tumor ≤12 cm from the anal verge

Exclusion Criteria:

1. Allergy to monoclonal antibodies, AK112 components, or CapeOX regimen.
2. Previous or current use of immune checkpoint inhibitors or immune-related 3.treatments.

4.Active autoimmune diseases or history of significant autoimmune conditions. 5.Immunodeficiency disorders or history of organ/bone marrow transplantation. 6.Uncontrolled cardiovascular conditions (e.g., heart failure, unstable angina, recent MI).

7.Severe infection within 4 weeks or active pulmonary infections. 8.Active hepatitis B or C infection. 9.Diagnosis of other malignancies within 5 years (except low-risk cancers). 10.Pregnant or breastfeeding women.

Where it's running

• Daping Hospital
  Chongqing, Chongqing Municipality, China Recruiting

Study contacts

• Study coordinator: Fan LI, PhD
• Email: levinecq@163.com
• Phone: +8618696539200

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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.