Short-course Radiotherapy Combined With Chemotherapy and Pd-1 Inhibitor for Locally Advanced Colon Cancer(TORCH-C)

Phase 2

Not yet recruiting

• Conditions: Locally Advanced Colon Cancer
• Interventions: Drug: Serplulimab; Radiation: short-term radiotherapy; Drug: Oxaliplatin; Drug: Capecitabine

• Registration Number: NCT05732493
• Lead Sponsor: Fudan University

Brief Summary

The study evaluates the combination of immunotherapy of PD-1 antibody and chemotherapy and neoadjuvant short-course radiotherapy in locally advanced colon cancer (LACC). Patients are randomly assigned into two prospective groups: treatment group and observerment group. In treatment group, a total of 60 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 surgery. In observerment group: a total of 60 patients will receive 4 cycles of CAPOX chemotherapy, then receive the surgery. The rate of pathologic complete response （pCR）, long-term prognosis and adverse effects will be analyzed.

Detailed Description

This study is a prospective, randomized controlled, multicenter phase II study, with a design of superior efficacy，to compare the efficacy of neoadjuvant short-course radiotherapy combined with CapOX chemotherapy and PD-1 immunotherapy in locally advanced colon cancer. We will consecutively enrolled patients who were diagnosed with locally advanced colon cancer with T4 stage or bulky nodes. A total of 120 patients will be Randomized 1:1 to the treatment group and observerment group. In observerment group, patients will receive 4 cycles of CAPOX (Capecitabine: 1000mg/m2 d1-14 q3w; Oxaliplatin: 130mg/m2 d1 q3w)chemotherapy, then receive the surgery, followed by 4 cycles of CAPOX. In treatment group, patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOXand PD-1 antibody(Serplulimab,300mg d1 q3w), then receive the surgery,followed by 4 cycles of CAPOX.

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-16
• Last Update Submitted: 2023-02-16
• Study First Posted: 2023-02-17
• Last Update Posted: 2023-02-17
• Study Start: 2023-03-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. pathological confirmed adenocarcinoma
2. clinical stage T4 and/or bulky nodes
3. the distance from anal verge more than 15 cm
4. without distance metastases
5. age >=18 years old, female and male
6. KPS >=70
7. without previous anti-cancer therapy or immunotherapy
8. with good compliance
9. signed the inform consent

Exclusion Criteria

1. pregnancy or breast-feeding women
2. history of other malignancies within 5 years
3. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
4. immunodeficiency disease or long-term using of immunosuppressive agents
5. 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
6. allergic to any component of the therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
short-course radiotherapy and immunotherapy	short-term radiotherapy	A total of 60 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the surgery.
short-course radiotherapy and immunotherapy	Oxaliplatin	A total of 60 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the surgery.
short-course radiotherapy and immunotherapy	Serplulimab	A total of 60 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the surgery.
short-course radiotherapy and immunotherapy	Capecitabine	A total of 60 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the surgery.
chemotherapy	Oxaliplatin	A total of 60 patients will receive 4 cycles of CAPOX chemotherapy ,then receive the surgery.
chemotherapy	Capecitabine	A total of 60 patients will receive 4 cycles of CAPOX chemotherapy ,then receive the surgery.

Primary Outcome Measures

Name	Time	Method
pCR	The pCR rate will be evaluated after surgery, an average of 4 weeks	pCR was defined as the absence, from surgical samples, of malignant cells in the primary site and regional lymph nodes

Secondary Outcome Measures

Name	Time	Method
Grade 3-4 adverse effects rate	From date of randomization until the date of death from any cause, assessed up to 5 years	Rate of chemotherapy, radiotherapy and immunotherapy related severe adverse events
Surgical complications	The surgery was scheduled 2-4 weeks after the end of neoadjuvant therapy. And the surgical complications were assessed up to 5 years from the surgery	Rate of surgical complications, such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc.
R0 resection rate	The R0 resection rate will be evaluated after surgery, an average of 4 weeks	R0 resection refers to the complete removal of the tumor in the operation with microscopically negative margins
3 year overall survival rate	From date of randomization until the date of death from any cause, assessed up to 3 years	Rate of 3 years overall survival
3 year disease free survival rate	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.	Rate of 3 years disease free survival
3 year local recurrence free survival rate	From date of randomization until the date of first documented local-regional failure, assessed up to 3 years	Rate of 3 years local recurrence free survival