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Chemotherapy and Tislelizumab With Split-course HFRT for Locally Advanced Rectal Cancer

NCT05176964 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-09-25

No results posted yet for this study

Summary

The question of how to administer adequate chemotherapy and immunotherapy to synchronise hypofraction radiotherapy （HFRT） treatment strategy to maximise the benefits of neoadjuvant therapy for the improved prognosis of patients with locally advanced rectal cancer (LARC).We aimed to study whether chemotherapy and tislelizumab plus split-course HFRT results in better outcomes in LARC patients.

Conditions

Interventions

RADIATION

split-course HFRT

7Gy/F, d7, q3w, 5 cycles

DRUG

CAPOX chemotherapy

CAPOX chemotherapy will commence on day 1 for each of six cycles: oxaliplatin 130 mg/m\^2 intravenous infusion on day 1,followed by capecitabine 1000 mg/m\^2 administered orally twice daily on day 1 to 14 of a 21-day cycle.

DRUG

Tislelizumab

Tislelizumab 200 mg intravenous infusion on day 1 of each 21-day cycle for each of six cycles.

Sponsors & Collaborators

  • Fujian Medical University Union Hospital

    lead OTHER

Principal Investigators

  • Benhua Xu · Fujian Medical University Union Hospital

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05176964 on ClinicalTrials.gov