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

NCT05176964 | Unknown

• 1 other identifier: FujianUnionH-HFRT
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Rectal Cancer; Radiation Oncology

Keywords

chemotherapy; tislelizumab; split-course hypofraction radiotherapy; locally advanced rectal cancer

Outcome Measures

Primary Outcomes (1)

• pathological complete response(pCR)

  pCR is defined as no residual tumor in the surgical specimen.

  1 year

Secondary Outcomes (6)

• 3-year disease-free survival

  2 years

• local recurrence rate

  3 years

• overall survival(OS)

  5 years

• Sphincter-sparing surgery rate

  1 year

• R0 Resection Rate(R0-R)

  1 year

Study Arms (1)

HFRT with concurrent chemotherapy and immunotherapy

CAPOX chemotherapy plus tislelizumab treatment plus split-course HFRT

Radiation: split-course HFRT; Drug: CAPOX chemotherapy; Drug: Tislelizumab

Interventions

split-course HFRT RADIATION

7Gy/F, d7, q3w, 5 cycles

Also known as: hypofraction radiotherapy

HFRT with concurrent chemotherapy and immunotherapy

CAPOX chemotherapy DRUG

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.

Also known as: oxaliplatin and capecitabine

HFRT with concurrent chemotherapy and immunotherapy

Tislelizumab DRUG

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

Also known as: immunotherapy

HFRT with concurrent chemotherapy and immunotherapy

Eligibility Criteria

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

Study Population

Hosptal in-patients

You may qualify if:

• Treatment-naïve patients with operable locally advanced cancer (LARC, T3-4 and/or N+)
• Pathologically diagnosed as rectal adenocarcinoma
• Male or non-pregnant female
• Age: 18-70 years old
• Hematology examination：I. White blood cell count ≥4×10\^9/L;II. Neutrophils ≥1.5×10\^9/L;III. Platelet count ≥100×10\^9/L;IV. Hemoglobin ≥9g/L
• Blood biochemical examination: total bilirubin, AST, ALT≤2.0×upper limit of normal; creatinine≤1.5×upper limit of normal
• Functional status: ECOG score 0-1 points or KPS score ≥70 points
• Obtain the patient's informed consent

You may not qualify if:

• Pathologically diagnosed as non-adenocarcinoma
• Age\> 70 years old
• Patients with recurrence and distant metastasis
• Have a history of other malignancies
• Have had radiotherapy and/or chemotherapy
• Pregnant or breastfeeding women
• Mentally disordered
• Patients with severe heart, liver, and kidney damage
• Non-compliance or the investigator believes that the patient cannot complete the entire trial treatment

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

RECRUITING

Related Publications (1)

• Zheng R, Wang BS, Li Z, Chi P, Xu B. Combining chemotherapy and tislelizumab with preoperative split-course hypofraction radiotherapy for locally advanced rectal cancer: study protocol of a prospective, single-arm, phase II trial. BMJ Open. 2023 Mar 16;13(3):e066976. doi: 10.1136/bmjopen-2022-066976.

  PMID: 36927585 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, tumor tissue

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Oxaliplatin; Capecitabine; tislelizumab; Immunotherapy

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)

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; Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Benhua Xu

  Fujian Medical University Union Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benhua Xu

CONTACT

86+13696884375; benhuaxu@163.com

Mengxia Zhang

CONTACT

86+18305932021; 18898534045@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: January 4, 2022
• Study Start: December 31, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: September 25, 2023

Record last verified: 2023-09

Locations

CN (1)