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
- Name: Zhen Zhang
- Phone Number: 021-64175590
- Email: zhen_zhang@fudan.edu.cn
Study Locations
-
-
-
Shanghai, China
- Recruiting
- Fudan University Shanghai Cancer Center
-
Contact:
- Zhen Zhang, MD, PHD
- Phone Number: 021-64175590
- Email: zhen_zhang@fudan.edu.cn
-
-
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:
- age 18-75 years old, female and male
- pathological confirmed adenocarcinoma
- the distance from anal verge ≤ 7 cm
- 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.
- refuse radical surgery
- without pelvic or distance metastases
- KPS >=70
- with good compliance
- microsatellite repair status is MSS/pMMR
- without previous anti-cancer therapy or immunotherapy
- signed the inform consent
Exclusion Criteria:
- pregnancy or breast-feeding women
- pathological confirmed signet ring cell carcinoma
- 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
- DPD deficiency
- 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.
|
PD-1 antibody (Toripalimab): 240mg d1 q3w
Other Names:
Capecitabine: 1000mg/m2 d1-14 q3w
Other Names:
Oxaliplatin: 130mg/m2 d1 q3w
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
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
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunologic Factors
- Antibodies
- Capecitabine
- Oxaliplatin
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.