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

NCT ID: NCT05732493

Last Updated: 2023-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-12-31

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.

Conditions

Locally Advanced Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

short-course radiotherapy and immunotherapy

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.

Group Type: EXPERIMENTAL

Serplulimab

Intervention Type: DRUG

Serplulimab 300mg, d1, q3w

short-term radiotherapy

Intervention Type: RADIATION

radiation: 25Gy/5Fx

Oxaliplatin

Intervention Type: DRUG

130mg/m2 d1 q3w

Capecitabine

Intervention Type: DRUG

1000mg/m2 d1-14 q3w

chemotherapy

A total of 60 patients will receive 4 cycles of CAPOX chemotherapy ,then receive the surgery.

Group Type: ACTIVE_COMPARATOR

Oxaliplatin

Intervention Type: DRUG

130mg/m2 d1 q3w

Capecitabine

Intervention Type: DRUG

1000mg/m2 d1-14 q3w

Interventions

Serplulimab

Serplulimab 300mg, d1, q3w

Intervention Type: DRUG

short-term radiotherapy

radiation: 25Gy/5Fx

Intervention Type: RADIATION

Oxaliplatin

130mg/m2 d1 q3w

Intervention Type: DRUG

Capecitabine

1000mg/m2 d1-14 q3w

Intervention Type: DRUG

Other Intervention Names

Shor-course radiotherapy: 25Gy/5Fx; Xeloda

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhen Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Zhang H, Li Y, Xia F, Sun Y, Shen L, Wan J, Chen Y, Wang Y, Zhou M, Wu R, Zhou S, Wang Y, Liu F, Cai S, Zhang Z. Study protocol of short-course radiotherapy combined with CAPOX and PD-1 inhibitor for locally advanced colon cancer: a randomised, prospective, multicentre, phase II trial (TORCH-C). BMJ Open. 2024 Feb 2;14(2):e079442. doi: 10.1136/bmjopen-2023-079442.

Reference Type: DERIVED

PMID: 38309748 (View on PubMed)

Other Identifiers

NeoCRT-COLON

Identifier Type: -

Identifier Source: org_study_id