The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Early Rectal Cancer

NCT05555888 | Recruiting Phase 2

• 1 other identifier: FDRT-2022-227-2945
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 (cCR+pCR), Organ retention rate, long-term prognosis, and adverse effects will be analyzed.

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.

  The status of cCR will be evaluated after the completion of neoadjuvant therapy. The pCR rate will be evaluated after surgery. The cCR patients who adopted W&W strategy will be included into the CR rate caluculation.

Secondary Outcomes (6)

• Organ preservation rate

  from date of receiving neoadjuvant therapy, assessed up to 2 years

• 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

• 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 (1)

Treatment Arm

EXPERIMENTAL

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

Interventions

PD-1 antibody DRUG

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

Also known as: Toripalimab

Treatment Arm

Capecitabine DRUG

Capecitabine: 1000mg/m2 d1-14 q3w

Also known as: Xeloda

Treatment Arm

Oxaliplatin DRUG

Oxaliplatin: 130mg/m2 d1 q3w

Treatment Arm

Short-course radiotherapy RADIATION

Shor-course radiotherapy: 25Gy/5Fx

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• Chen Y, Wang Y, Zhang H, Wan J, Shen L, Wang Y, Zhou M, Wu R, Yang W, Zhou S, Cai S, Li X, Zhang Z, Xia F. Short-course radiotherapy combined with chemotherapy and PD-1 inhibitor in low-lying early rectal cancer: study protocol for a single-arm, multicentre, prospective, phase II trial (TORCH-E). BMJ Open. 2023 Oct 6;13(10):e076048. doi: 10.1136/bmjopen-2023-076048.

  PMID: 37802608 DERIVED

MeSH Terms

Interventions

spartalizumab; toripalimab; Capecitabine; Oxaliplatin

Intervention Hierarchy (Ancestors)

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, M.D, PH.D

CONTACT

18801735029; 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: September 22, 2022
• First Posted: September 27, 2022
• Study Start: December 12, 2022
• Primary Completion: March 12, 2024
• Study Completion: May 1, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 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)