Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer

NCT06462053 | Recruiting Phase 2

• 1 other identifier: FDRT-2023-377-3496
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

TORCH-E2 is a prospective, multicentre, randomized phase II trial. 134 low-lying early (T1-3b/N0-1M0, distance from anal verge ≤5cm) patients will be recruited and assigned to Group 1 and Group 2 (1:1). Group 1 receives SCRT (25Gy/5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. Group 2 receives LCRT (50Gy/25Fx) followed by 2 cycles of CAPOX. A WW option can be applied to patients achieving cCR while surgery will be recommended for those who fail to achieve cCR. The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.

Conditions

Early Low Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• complete response (CR) rate

  Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W\&W strategy.

  1 month after the surgery or the decision of W&W

Secondary Outcomes (6)

• Grade 3-4 adverse effects rate

  From date of randomization until 3 months after the completion neoadjuvant therapy

• Organ preservation rate

  from date of receiving neoadjuvant therapy, assessed up to 3 years

• 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.

• 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.

• 3 year overall survival rate

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

Study Arms (2)

Short-course Radiotherapy plus immunochemotherapy group

EXPERIMENTAL

The patients will receive short-course radiotherapy (25Gy/5Fx, SCRT), followed by 4 cycles of CAPOX and PD-1 antibody, finally receive the TEM or TME surgery or adopt WW option.

Radiation: Short-course radiotherapy; Drug: PD-1 antibody (Toripalimab); Drug: Oxaliplatin; Drug: Capecitabine

Long-course Radiotherapy plus chemotherapy group

EXPERIMENTAL

The patients will receive long-course radiotherapy (50Gy/25Fx,LCRT, concurrent capecitabine), followed by 2 cycles of CAPOX, finally receive the TEM or TME surgery or adopt WW option.

Radiation: Long-course radiotherapy; Drug: Oxaliplatin; Drug: Capecitabine

Interventions

Short-course radiotherapy RADIATION

Short-course radiotherapy: 25Gy/5Fx

Also known as: SCRT

Short-course Radiotherapy plus immunochemotherapy group

PD-1 antibody (Toripalimab) DRUG

Toripalimab 240mg d1 q3w

Also known as: Toripalimab

Short-course Radiotherapy plus immunochemotherapy group

Long-course radiotherapy RADIATION

Long-course radiation: 50Gy/25Fx

Also known as: LCRT

Long-course Radiotherapy plus chemotherapy group

Oxaliplatin DRUG

Oxaliplatin: 130mg/m2 d1 q3w

Long-course Radiotherapy plus chemotherapy group; Short-course Radiotherapy plus immunochemotherapy group

Capecitabine DRUG

Xeloda

Also known as: Xeloda

Long-course Radiotherapy plus chemotherapy group; Short-course Radiotherapy plus immunochemotherapy group

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
• clinical stage T1-3bN0-1, 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Interventions

toripalimab; Oxaliplatin; Capecitabine

Intervention Hierarchy (Ancestors)

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

Study Officials

• Zhen Zhang, M.D, PH.D

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen Zhang, M.D, PH.D

CONTACT

18801735029; zhen_zhang@fudan.edu.cn

Yajie Chen, PH.D

CONTACT

18917239680; 16111230008@fudan.edu.cn

Study Design

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

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

CN (1)