Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer

Phase 2RecruitingNCT06462053

Fudan University134 enrolled

Overview

TORCH-E2 is a prospective, multicentre, randomized phase II trial. 134 low-lying early (T1-3b/N0-1M0, distance from anal verge ≤5cm) patients will be recruited and assigned to Group 1 and Group 2 (1:1). Group 1 receives SCRT (25Gy/5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. Group 2 receives LCRT (50Gy/25Fx) followed by 2 cycles of CAPOX. A WW option can be applied to patients achieving cCR while surgery will be recommended for those who fail to achieve cCR. The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

134

Conditions

Early Low Rectal Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. age 18-75 years old, female and male 2. pathological confirmed adenocarcinoma 3. clinical stage T1-3bN0-1, tumor maximum diameter less than 4cm 4. the distance from anal verge less than 5 cm 5. without distance metastases 6. KPS \>=70 7. with good compliance 8. microsatellite repair status is MSS/pMMR 9. without previous anti-cancer therapy or immunotherapy 10. signed the inform consent Exclusion Criteria: 1. pregnancy or breast-feeding women 2. pathological confirmed signet ring cell carcinoma 3. clinical stage T1N0 and can be resected locally 4. history of other malignancies within 5 years 5. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc. 6. immunodeficiency disease or long-term using of immunosuppressive agents 7. baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN 8. DPD deficiency 9. allergic to any component of the therapy

Outcomes

Primary Outcomes

complete response (CR) rate

Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W\&W strategy.

Time frame: 1 month after the surgery or the decision of W&W

Secondary Outcomes

Grade 3-4 adverse effects rate

Rate of chemotherapy, radiotherapy and immunotherapy related adverse events

Time frame: From date of randomization until 3 months after the completion neoadjuvant therapy

Organ preservation rate

Time frame: from date of receiving neoadjuvant therapy, assessed up to 3 years

3 year disease free survival rate

Rate of 3 year disease free survival

Time frame: From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.

3 year local recurrence free survival rate

Rate of 3 year local recurrence free survival

Time frame: From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.

3 year overall survival rate

Rate of 3 year overall survival

Time frame: From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.

3 year Quality of Life

Quality of life will be evaluated using EORTC QLQ-C30, EORTC QLQ-CR29, LARS score and Wexner score.

Time frame: From date of initiation of treatment until the date of death from any cause, assessed up to 3 years