Short-course Radiotherapy Combined With Chemotherapy and Pd-1 Inhibitor for Locally Advanced Colon Cancer(TORCH-C)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: Serplulimab
Serplulimab 300mg, d1, q3w
Radiation: short-term radiotherapy
radiation: 25Gy/5Fx
Other Names:
Drug: Oxaliplatin
130mg/m2 d1 q3w
Drug: Capecitabine
1000mg/m2 d1-14 q3w
Other Names:
|
| Active Comparator: chemotherapy A total of 60 patients will receive 4 cycles of CAPOX chemotherapy ,then receive the surgery. |
Drug: Oxaliplatin
130mg/m2 d1 q3w
Drug: Capecitabine
1000mg/m2 d1-14 q3w
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
pathological confirmed adenocarcinoma
-
clinical stage T4 and/or bulky nodes
-
the distance from anal verge more than 15 cm
-
without distance metastases
-
age >=18 years old, female and male
-
KPS >=70
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without previous anti-cancer therapy or immunotherapy
-
with good compliance
-
signed the inform consent
Exclusion Criteria:
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pregnancy or breast-feeding women
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history of other malignancies within 5 years
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serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
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immunodeficiency disease or long-term using of immunosuppressive agents
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baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×109/L, Hb≥90g/L, PLT≥100×109/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
-
allergic to any component of the therapy
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fudan University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NeoCRT-COLON