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RECRUITINGPhase 2INTERVENTIONAL

Neoadjuvant Short-Course Radiotherapy With or Without Chemotherapy and AK112 in 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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This phase II multicenter, randomized study evaluates the safety and efficacy of neoadjuvant short-course radiotherapy (SCRT) sequentially combined with AK112 (Envafolimab) with or without chemotherapy in patients with locally advanced rectal cancer (LARC). The study also aims to identify biomarkers predicting tumor response and develop efficacy prediction models.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Signed written willing to sign a consent form. 2. Age 18-80 years, male or female. 3. diagnosed by tissue sample (biopsy-confirmed) rectal adenocarcinoma. 4. Clinical baseline stage T3-4NxM0 or TxN1-2M0 by MRI assessment. 5. Able to swallow tablets. 6. You should be able to carry out daily activities with 0 level of ability (ECOG 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 Who Should NOT Join This Trial: 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 conditions (where your immune system attacks your own body)s or history of significant autoimmune conditions. 5.weakened immune system 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

AK112 with SCRT and CapeOX

In the 1st week, neoadjuvant short-course radiotherapy will be administered (25 Gy in 5 fractions over 5 days). After a 7day interval, patients will receive 2 cycles of CapeOX chemotherapy combined with AK112 (every 3 weeks; Day 1: Oxaliplatin, 130 mg/m², IV infusion; Day 1: AK112, 20 mg/kg, IV infusion; Day 1 to Day 14: Capecitabine, 850-1000 mg/m², BID, orally).

DRUG

AK112 with SCRT

In the 1st week, neoadjuvant short-course radiotherapy will be administered (25 Gy in 5 fractions over 5 days). After a 7-day interval, patients will receive 2 cycles of AK112 treatment (Day 1: AK112, 20 mg/kg, IV infusion).

Locations (1)

Daping Hospital
Chongqing, Chongqing Municipality, China