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Trial Title:
Short-course Radiotherapy Combined With Chemotherapy and Pd-1 Inhibitor for Locally Advanced Colon Cancer(TORCH-C)
NCT ID:
NCT05732493
Condition:
Locally Advanced Colon Cancer
Conditions: Official terms:
Colonic Neoplasms
Capecitabine
Oxaliplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Serplulimab
Description:
Serplulimab 300mg, d1, q3w
Arm group label:
short-course radiotherapy and immunotherapy
Intervention type:
Radiation
Intervention name:
short-term radiotherapy
Description:
radiation: 25Gy/5Fx
Arm group label:
short-course radiotherapy and immunotherapy
Other name:
Shor-course radiotherapy: 25Gy/5Fx
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
130mg/m2 d1 q3w
Arm group label:
chemotherapy
Arm group label:
short-course radiotherapy and immunotherapy
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
1000mg/m2 d1-14 q3w
Arm group label:
chemotherapy
Arm group label:
short-course radiotherapy and immunotherapy
Other name:
Xeloda
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
March 1, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05732493
