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

Sponsor
Fudan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05555888
Collaborator
(none)
34
Enrollment
1
Location
1
Arm
33.8
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective Phase II Trial of Immunotherapy Combined With Short-course Radiotherapy in Early Low Rectal Cancer
Anticipated Study Start Date :
Jan 8, 2023
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Arm

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.

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: Short-course radiotherapy
    Shor-course radiotherapy: 25Gy/5Fx

    Outcome Measures

    Primary Outcome Measures

    1. complete response (CR) rate [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.]

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

    Secondary Outcome Measures

    1. Organ preservation rate [from date of receiving neoadjuvant therapy, assessed up to 2 years]

      Rate of cCR or near-cCR after neoadjuvant therapy underwent nonsurgical treatment or radical resection

    2. Grade 3-4 adverse effects rate [From date of initiation of treatment until the date of death from any cause, assessed up to 5 years]

      Rate of chemotherapy, radiotherapy and immunotherapy related adverse events

    3. 3 year disease free survival rate [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

    4. 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.]

      Rate of 3 year local recurrence free survival

    5. 3 year overall survival rate [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

    6. 10 year Quality of Life [From date of initiation of treatment until the date of death from any cause, assessed up to 10 years]

      Quality of life will be evaluated using EORTC QLQ-C30, EORTC QLQ-CR29, LARS score and Wexner score.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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≥1.5×109/L, Hb≥90g/L, PLT≥100×109/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN

    8. DPD deficiency

    9. allergic to any component of the therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fudan University Shanghai Cancer Center Shanghai Shanghai China 200032

    Sponsors and Collaborators

    • Fudan University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhen Zhang, Professor, Fudan University
    ClinicalTrials.gov Identifier:
    NCT05555888
    Other Study ID Numbers:
    • FDRT-2022-227-2945
    First Posted:
    Sep 27, 2022
    Last Update Posted:
    Jan 11, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Rectal Neoplasms
    Capecitabine
    Oxaliplatin
    Antibodies

    Study Results

    No Results Posted as of Jan 11, 2023