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The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Early Rectal Cancer (TORCH-E） (TORCH-E)

Primary Purpose

Early Low Rectal Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
PD-1 antibody
Capecitabine
Oxaliplatin
Short-course radiotherapy
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Low Rectal Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. age 18-70 years old, female and male
  2. pathological confirmed adenocarcinoma
  3. clinical stage T1-3bN0, tumor maximum diameter less than 4cm
  4. the distance from anal verge less than 5 cm
  5. without distance metastases
  6. KPS >=70
  7. with good compliance
  8. microsatellite repair status is MSS/pMMR
  9. without previous anti-cancer therapy or immunotherapy
  10. signed the inform consent

Exclusion Criteria:

  1. pregnancy or breast-feeding women
  2. pathological confirmed signet ring cell carcinoma
  3. clinical stage T1N0 and can be resected locally
  4. history of other malignancies within 5 years
  5. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
  6. immunodeficiency disease or long-term using of immunosuppressive agents
  7. 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
  8. DPD deficiency
  9. allergic to any component of the therapy

Sites / Locations

  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

A total of 34 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the TEM or TME surgery.

Outcomes

Primary Outcome Measures

complete response (CR) rate
Rate of complete response (CR), including pathologic complete response (pCR) and sustained cCR for ≥ 1 year.

Secondary Outcome Measures

Organ preservation rate
Rate of cCR or near-cCR after neoadjuvant therapy underwent nonsurgical treatment or radical resection
Grade 3-4 adverse effects rate
Rate of chemotherapy, radiotherapy and immunotherapy related adverse events
3 year disease free survival rate
Rate of 3 year disease free survival
3 year local recurrence free survival rate
Rate of 3 year local recurrence free survival
3 year overall survival rate
Rate of 3 year overall survival
10 year Quality of Life
Quality of life will be evaluated using EORTC QLQ-C30, EORTC QLQ-CR29, LARS score and Wexner score.

Full Information

First Posted
September 22, 2022
Last Updated
September 15, 2023
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05555888
Brief Title
The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Early Rectal Cancer (TORCH-E）
Acronym
TORCH-E
Official Title
A Prospective Phase II Trial of Immunotherapy Combined With Short-course Radiotherapy in Early Low Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The study evaluates the combination of immunotherapy of PD-1 antibody and neoadjuvant short-course radiotherapy in early low rectal cancer. A total of 34 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 local excision(TEM) or total mesorectal excision (TME). The rate of complete response (CR, pCR + sustained cCR for ≥ 1 year), Organ retention rate, long-term prognosis, and adverse effects will be analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Low Rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
A total of 34 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the TEM or TME surgery.
Intervention Type
Drug
Intervention Name(s)
PD-1 antibody
Other Intervention Name(s)
Toripalimab
Intervention Description
PD-1 antibody (Toripalimab): 240mg d1 q3w
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
Capecitabine: 1000mg/m2 d1-14 q3w
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Oxaliplatin: 130mg/m2 d1 q3w
Intervention Type
Radiation
Intervention Name(s)
Short-course radiotherapy
Intervention Description
Shor-course radiotherapy: 25Gy/5Fx
Primary Outcome Measure Information:
Title
complete response (CR) rate
Description
Rate of complete response (CR), including pathologic complete response (pCR) and sustained cCR for ≥ 1 year.
Time Frame
The status of cCR will be evaluated after the completion of neoadjuvant therapy. The pCR rate will be evaluated after surgery. The W&W patients with cCR for ≥ 1 year will be included into the CR rate caluculation.
Secondary Outcome Measure Information:
Title
Organ preservation rate
Description
Rate of cCR or near-cCR after neoadjuvant therapy underwent nonsurgical treatment or radical resection
Time Frame
from date of receiving neoadjuvant therapy, assessed up to 2 years
Title
Grade 3-4 adverse effects rate
Description
Rate of chemotherapy, radiotherapy and immunotherapy related adverse events
Time Frame
From date of initiation of treatment until the date of death from any cause, assessed up to 5 years
Title
3 year disease free survival rate
Description
Rate of 3 year disease free survival
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.
Title
3 year local recurrence free survival rate
Description
Rate of 3 year local recurrence free survival
Time Frame
From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.
Title
3 year overall survival rate
Description
Rate of 3 year overall survival
Time Frame
From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.
Title
10 year Quality of Life
Description
Quality of life will be evaluated using EORTC QLQ-C30, EORTC QLQ-CR29, LARS score and Wexner score.
Time Frame
From date of initiation of treatment until the date of death from any cause, assessed up to 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18-70 years old, female and male pathological confirmed adenocarcinoma clinical stage T1-3bN0, tumor maximum diameter less than 4cm the distance from anal verge less than 5 cm without 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 clinical stage T1N0 and can be resected locally 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen Zhang, M.D, PH.D
Phone
18801735029
Ext
18801735029
Email
zhen_zhang@fudan.edu.cn
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen Zhang, M.D, PH.D
Phone
19521280960
Email
zhen_zhang@fudan.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 3 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).

Learn more about this trial

The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Early Rectal Cancer (TORCH-E）

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