Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)

June 12, 2024 updated by: Zhen Zhang, Fudan University
This is a single arm phase II study to explore the 3y LRFS and safety for high-risk early rectal cancer after local excision with short-course radiotherapy and chemo-immunotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A total of 60 patients with high-risk pathologic stage pT1 or pT2 cancer after local excision but refused radical surgery will be included.

Eligibility criteria include a histological diagnosis of adenocarcinoma located ≤7 cm from the anal verge, pT1 after local excision of the primary rectal cancer, with one of the high-risk features including margin positivity/very close margin (<1mm) at time of local excision, depth of invasion >1 mm or SM3 invasion (submucosal invasion to the lower third of the submucosal level), high grade or poorly differentiated, lymphovascular invasion, perineural invasion, tumour budding, or pT2 tumor.

They will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. age 18-75 years old, female and male
  2. pathological confirmed adenocarcinoma
  3. the distance from anal verge ≤ 7 cm
  4. pT1 after local excision of the primary rectal cancer, with at least one of the high-risk features including margin positivity/very close margin (<1mm) at time of local excision, depth of invasion >1 mm or SM3 invasion (submucosal invasion to the lower third of the submucosal level), high grade or poorly differentiated, lymphovascular invasion, perineural invasion, tumour budding, or pT2 tumor.
  5. refuse radical surgery
  6. without pelvic or distance metastases
  7. KPS >=70
  8. with good compliance
  9. microsatellite repair status is MSS/pMMR
  10. without previous anti-cancer therapy or immunotherapy
  11. signed the inform consent

Exclusion Criteria:

  1. pregnancy or breast-feeding women
  2. pathological confirmed signet ring cell carcinoma
  3. history of other malignancies within 5 years
  4. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
  5. immunodeficiency disease or long-term using of immunosuppressive agents
  6. 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
  7. DPD deficiency
  8. 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm1
Patients will receive short course radiotherapy and four cycles of CapeOx and PD-1 inhibitor.
Drug: PD-1 antibody
PD-1 antibody (Toripalimab): 240mg d1 q3w
Other Names:
  • Toripalimab
Drug: Capecitabine
Capecitabine: 1000mg/m2 d1-14 q3w
Other Names:
  • Xeloda
Drug: Oxaliplatin
Oxaliplatin: 130mg/m2 d1 q3w
Radiation: Radiation
Shor-course radiotherapy: 25Gy/5Fx

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3y LRFS
Time Frame: From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.
Rate of 3 year local recurrence free survival rate
From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3y DFS
Time Frame: From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Rate of 3 year disease free survival
From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
3y OS
Time Frame: From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.
Rate of 3 year overall survival
From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.
Grade 3-4 adverse effects rate
Time Frame: From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.
Rate of chemotherapy, radiotherapy and immunotherapy related adverse events
From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.

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 (Actual)

May 8, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

June 6, 2024

First Submitted That Met QC Criteria

June 6, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 12, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDRT-2024-31-3584

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in the related article, after deidentification (text, tables, figures, and appendices).

IPD Sharing Time Frame

Beginning 12 months and ending 5 years following related article publication.

IPD Sharing Access Criteria

Proposals should be directed to xxx@yyy. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link will to be included).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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.

Clinical Trials on Rectal Cancer

Clinical Trials on PD-1 antibody

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe