A Phase 2 interventional study of AK112 with SCRT and CapeOX and AK112 with SCRT in Rectal Cancer, sponsored by fan li. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-10.
Sponsored by fan li · Phase 2, Interventional, and Treatment
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.
The study is designed as a two-arm, randomized, open-label, prospective trial. Patients with locally advanced rectal adenocarcinoma will be randomly assigned to one of two treatment groups:
Arm A: SCRT followed by chemotherapy (CapeOX) combined with AK112. Arm B: SCRT followed by AK112 alone. Primary and secondary outcome measures include complete response rate (CR), safety, pathological and radiological response rates, and biomarkers associated with treatment response. The trial will enroll 100 participants across multiple centers over three years.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 100 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →fan li is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
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9.Fit for surgery with no contraindications. 10.Normal organ function. 11.Tumor ≤12 cm from the anal verge
Exclusion Criteria:
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.
Patients will receive short-course radiotherapy (SCRT) followed by chemotherapy (CapeOX regimen) combined with AK112: 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 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 and CapeOX
Patients will receive short-course radiotherapy (SCRT) followed by AK112: 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).
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 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).
Also known as: short-course radiotherapy, CapeOX
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).
Complete Response Rate
Proportion of patients achieving either a pathological complete response (pCR) or a clinical complete response (cCR).
Time frame: From treatment initiation to post-neoadjuvant therapy evaluation (approximately 12 weeks).
Adverse Events (AEs)
Incidence, type, and severity of adverse events graded according to CTCAE v5.0, including their correlation with the study drug.
Time frame: From baseline to 90 days after the last treatment dose.
Major Pathological Response (MPR)
Proportion of patients with ≤10% residual viable tumor cells in resected specimens.
Time frame: At the time of surgery (approximately 12 weeks after treatment initiation).
Objective Response Rate (ORR)
Proportion of patients with complete response (CR) or partial response (PR) based on radiological assessments using RECIST 1.1 criteria.
Time frame: Approximately 12 weeks after treatment initiation.
Progression-Free Survival (PFS)
Time from randomization to disease progression or death from any cause.
Time frame: Up to 36 months post-randomization.
Overall Survival (OS)
Time from randomization to death from any cause.
Time frame: Up to 36 months post-randomization.
Organ Preservation Rate (OPR)
Proportion of patients avoiding major surgery while retaining organ functionality.
Time frame: Approximately 12 months post-treatment initiation.
Tumor Response Based on RECIST 1.1
Evaluation of complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) using RECIST 1.1 criteria.
Time frame: Approximately 12 weeks after treatment initiation.
Clinical Complete Response Rate (cCR)
Proportion of patients achieving clinical complete response based on clinical examination and imaging assessments.
Time frame: Approximately 12 weeks after treatment initiation.
Pathological Complete Response (pCR)
Absence of tumor cells in the primary tumor and regional lymph nodes in surgical specimens.
Time frame: Approximately 12 weeks after treatment initiation.
Plan to share: No
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