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

Locally Advanced Colon Cancer Clinical Trial

— TORCH-C  

Official title:

Short-course Radiotherapy Combined With CAPOX and Pd-1 Inhibitor for Locally Advanced Colon Cancer: a Randomized, Prospective, Multicentre, Phase II Trial (TORCH-C)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05732493
• Other study ID #: NeoCRT-COLON
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Locally Advanced Colon Cancer

Intervention

Drug:
• Serplulimab
Serplulimab 300mg, d1, q3w

Radiation:
• short-term radiotherapy
radiation: 25Gy/5Fx

Drug:
• Oxaliplatin
130mg/m2 d1 q3w
• Capecitabine
1000mg/m2 d1-14 q3w

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pCR	pCR was defined as the absence, from surgical samples, of malignant cells in the primary site and regional lymph nodes	The pCR rate will be evaluated after surgery, an average of 4 weeks
Secondary	R0 resection rate	R0 resection refers to the complete removal of the tumor in the operation with microscopically negative margins	The R0 resection rate will be evaluated after surgery, an average of 4 weeks
Secondary	3 year overall survival rate	Rate of 3 years overall survival	From date of randomization until the date of death from any cause, assessed up to 3 years
Secondary	3 year disease free survival rate	Rate of 3 years disease free survival	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.
Secondary	Grade 3-4 adverse effects rate	Rate of chemotherapy, radiotherapy and immunotherapy related severe adverse events	From date of randomization until the date of death from any cause, assessed up to 5 years
Secondary	3 year local recurrence free survival rate	Rate of 3 years local recurrence free survival	From date of randomization until the date of first documented local-regional failure, assessed up to 3 years
Secondary	Surgical complications	Rate of surgical complications, such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc.	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