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

NCT05732493 | Unknown Phase 2

• 1 other identifier: NeoCRT-COLON
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Locally Advanced Colon Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• R0 resection rate

  The R0 resection rate will be evaluated after surgery, an average of 4 weeks

• 3 year overall survival rate

  From date of randomization until the date of death from any cause, assessed up to 3 years

• 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.

• Grade 3-4 adverse effects rate

  From date of randomization until the date of death from any cause, assessed up to 5 years

• 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

Study Arms (2)

short-course radiotherapy and immunotherapy

EXPERIMENTAL

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

chemotherapy

ACTIVE COMPARATOR

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

Drug: Oxaliplatin; Drug: Capecitabine

Interventions

Serplulimab DRUG

Serplulimab 300mg, d1, q3w

short-course radiotherapy and immunotherapy

short-term radiotherapy RADIATION

radiation: 25Gy/5Fx

Also known as: Shor-course radiotherapy: 25Gy/5Fx

short-course radiotherapy and immunotherapy

Oxaliplatin DRUG

130mg/m2 d1 q3w

chemotherapy; short-course radiotherapy and immunotherapy

Capecitabine DRUG

1000mg/m2 d1-14 q3w

Also known as: Xeloda

chemotherapy; short-course radiotherapy and immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• without previous anti-cancer therapy or immunotherapy
• with good compliance
• signed the inform consent

You may not qualify if:

• pregnancy or breast-feeding women
• history of other malignancies within 5 years
• serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
• immunodeficiency disease or long-term using of immunosuppressive agents
• 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
• allergic to any component of the therapy

Sponsors & Collaborators

• Fudan University: lead

Related Publications (1)

• 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.

  PMID: 38309748 DERIVED

MeSH Terms

Interventions

Oxaliplatin; Capecitabine

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 17, 2023
• Study Start: March 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share