The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Early Rectal Cancer

Phase 2RecruitingNCT05555888

Fudan University34 enrolled

Overview

The study evaluates the combination of immunotherapy of PD-1 antibody and neoadjuvant short-course radiotherapy in early low rectal cancer. A total of 34 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody, finally receive the local excision(TEM) or total mesorectal excision (TME). The rate of complete response (cCR+pCR), Organ retention rate, long-term prognosis, and adverse effects will be analyzed.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Early Low Rectal Cancer

Interventions

PD-1 antibody

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. age 18-70 years old, female and male 2. pathological confirmed adenocarcinoma 3. clinical stage T1-3bN0, 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: The status of cCR will be evaluated after the completion of neoadjuvant therapy. The pCR rate will be evaluated after surgery. The cCR patients who adopted W&W strategy will be included into the CR rate caluculation.

Secondary Outcomes

Organ preservation rate

Rate of patients who underwent organ preservation via WW or TEM after neoadjuvant therapy

Time frame: from date of receiving neoadjuvant therapy, assessed up to 2 years

Grade 3-4 adverse effects rate

Rate of chemotherapy, radiotherapy and immunotherapy related adverse events

Time frame: From date of initiation of treatment until the date of death from any cause, assessed up to 5 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.

10 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 10 years