SCRT Combined With CAPOX and PD-1/CTLA4 Antibody for Early-stage Low Rectal Cancer

Phase 2Not Yet RecruitingNCT07837362

Fudan University34 enrolled

Overview

The study evaluates the combination of immunotherapy of PD-1/ CTLA4 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/ CTLA4 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

Shor-course radiotherapyRADIATION

Shor-course radiotherapy: 25Gy/5Fx

PD-1/CTLA4 AntibodyDRUG

Iparomlimab and Tuvonralimab, 5mg/kg, d1 q3w

CapecitabineDRUG

Capecitabine: 1000mg/m2 d1-14 q3w

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, 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

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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: From date of receiving neoadjuvant therapy, assessed up to 2 years

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

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

Patient self-assessment via EORTC QLQ-C30 questionnaire to monitor changes in quality of life throughout treatment.

Time frame: From date of initiation of treatment until the date of death from any cause, assessed up to 10 years

Grade 3-4 adverse effects rate

Central Contacts

Zhen Zhang, M.D, PH.D

CONTACT

18801735029 zhen_zhang@fudan.edu.cn

Data from ClinicalTrials.gov

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