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

NCT06455124 | Recruiting Phase 2

• 1 other identifier: FDRT-2024-31-3584
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Cancer

Keywords

early rectal cancer; high risk; local excision; radiation; PD-1 inhibitor; chemotherapy

Outcome Measures

Primary Outcomes (1)

• 3y LRFS

  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 Outcomes (3)

• 3y DFS

  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

  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

  From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.

Study Arms (1)

Arm1

EXPERIMENTAL

Patients will receive short course radiotherapy and four cycles of CapeOx and PD-1 inhibitor.

Radiation: Radiation; Drug: PD-1 antibody; Drug: Capecitabine; Drug: Oxaliplatin

Interventions

Radiation RADIATION

Shor-course radiotherapy: 25Gy/5Fx

Arm1

PD-1 antibody DRUG

PD-1 antibody (Toripalimab): 240mg d1 q3w

Also known as: Toripalimab

Arm1

Capecitabine DRUG

Capecitabine: 1000mg/m2 d1-14 q3w

Also known as: Xeloda

Arm1

Oxaliplatin DRUG

Oxaliplatin: 130mg/m2 d1 q3w

Arm1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Radiation; spartalizumab; toripalimab; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Central Study Contacts

Zhen Zhang

CONTACT

021-64175590; zhen_zhang@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: May 8, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2029
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 12 months and ending 5 years following related article publication.
• 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).

Locations

CN (1)