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

September 22, 2023 updated by: Benhua Xu, Fujian Medical University Union Hospital

Combined Chemotherapy and Tislelizumab With Preoperative Split-course Hypofraction Radiotherapy for Locally Advanced Rectal Cancer:Study Protocol of a Prospective, Single-arm Phase II Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prior to analyzing continuous variables, the statistical normality of the data will be determined. The differences between the main variables will be compared by using the analysis of variance. A comparison of data on categorical variables will be carried out by χ2 tests or Fisher's exact tests. The OS and PFS was estimated using the Kaplan-Meier method. PFS and OS will be compared using the log-rank test. In cases where variables must be adjusted, we will use the proportional hazard Cox regression model. P values for all analyses will be based on using a significance level of 0.05.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
          • Benhua Xu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Hosptal in-patients

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HFRT with concurrent chemotherapy and immunotherapy
CAPOX chemotherapy plus tislelizumab treatment plus split-course HFRT
Radiation: split-course HFRT
7Gy/F, d7, q3w, 5 cycles
Other Names:
  • hypofraction radiotherapy
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.
Other Names:
  • oxaliplatin and capecitabine
Drug: Tislelizumab
Tislelizumab 200 mg intravenous infusion on day 1 of each 21-day cycle for each of six cycles.
Other Names:
  • immunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pathological complete response(pCR)
Time Frame: 1 year
pCR is defined as no residual tumor in the surgical specimen.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year disease-free survival
Time Frame: 2 years
the time from randomization to disease recurrence or patient death due to disease progression.
2 years
local recurrence rate
Time Frame: 3 years
It's defined as disease-free proximal, distal and circumferential margins.And its progression was defined as an increase in tumor size.
3 years
overall survival(OS)
Time Frame: 5 years
It's defined as the time after the first dose of study therapy to death from any cause.
5 years
Sphincter-sparing surgery rate
Time Frame: 1 year
sphincter-sparing surgery rate
1 year
R0 Resection Rate(R0-R)
Time Frame: 1 year
It's defined as the percentage of patients undergoing resection, defined as a tumour-free resection margin.
1 year
predictive biomarkers andquality of life(QoL)
Time Frame: 3 years
Objective condition index include subjective perception index objective condition index and subjective perception index.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University Union Hospital

Investigators

  • Principal Investigator: Benhua Xu, Fujian Medical University Union Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 30, 2021

First Submitted That Met QC Criteria

December 15, 2021

First Posted (Actual)

January 4, 2022

Study Record Updates

Last Update Posted (Actual)

September 25, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FujianUnionH-HFRT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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