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

Fudan University

Status and phase: Not yet enrolling; Phase 2

Conditions: Locally Advanced Colon Cancer

Treatments: Radiation: short-term radiotherapy; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Serplulimab

Study type: Interventional

Funder types: Other

Identifiers

NCT05732493

NeoCRT-COLON

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

short-course radiotherapy and immunotherapy

Experimental group

Description:

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.

Treatment:

Drug: Oxaliplatin

Drug: Serplulimab

Drug: Capecitabine

Radiation: short-term radiotherapy

chemotherapy

Active Comparator group

Description:

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

Treatment:

Drug: Oxaliplatin

Drug: Capecitabine