Neoadjuvant treatment for locally advanced rectal cancer

A Multicenter, Randomized, Parallel, Non-Controlled, Prospective Phase II Study of Neoadjuvant Short-Course Radiotherapy Sequential With AK112 With or Without Chemotherapy for Locally Advanced Rectal Cancer

This study is testing a new treatment approach for locally advanced rectal cancer that combines short radiation therapy with a drug called AK112, with or without chemotherapy, to see how well it works and how safe it is.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, Envafolimab
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT06718543 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with histologically confirmed locally advanced rectal adenocarcinoma who have not received prior treatment.

Not a fit: Patients with active autoimmune diseases, prior use of immune checkpoint inhibitors, or significant cardiovascular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with locally advanced rectal cancer.

How similar studies have performed: Other studies have shown promise with similar neoadjuvant approaches, but this specific combination is novel.

Eligibility criteria

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 this trial is running

Chongqing, Chongqing Municipality

• Daping Hospital — Chongqing, Chongqing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Fan LI, PhD

Conditions Rectal Cancer; rectal cancer; neoadjuvant; Ivonescimab; Immunotherapy