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

February 16, 2023 updated by: Zhen Zhang, Fudan University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Shor-course radiotherapy: 25Gy/5Fx
Drug: Oxaliplatin
130mg/m2 d1 q3w
Drug: Capecitabine
1000mg/m2 d1-14 q3w
Other Names:
  • Xeloda
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:
  • Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pCR
Time Frame: 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
The pCR rate will be evaluated after surgery, an average of 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 resection rate
Time Frame: 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
The R0 resection rate will be evaluated after surgery, an average of 4 weeks
3 year overall survival rate
Time Frame: From date of randomization until the date of death from any cause, assessed up to 3 years
Rate of 3 years overall survival
From date of randomization until the date of death from any cause, assessed up to 3 years
3 year disease free survival rate
Time Frame: 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
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
Time Frame: 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
From date of randomization until the date of death from any cause, assessed up to 5 years
3 year local recurrence free survival rate
Time Frame: 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
From date of randomization until the date of first documented local-regional failure, assessed up to 3 years
Surgical complications
Time Frame: 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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

February 16, 2023

First Posted (Actual)

February 17, 2023

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NeoCRT-COLON

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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