Chemotherapy and Tislelizumab With Split-course HFRT for Locally Advanced Rectal Cancer
NCT ID: NCT05176964
Last Updated: 2023-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2021-12-31
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HFRT with concurrent chemotherapy and immunotherapy
CAPOX chemotherapy plus tislelizumab treatment plus split-course HFRT
split-course HFRT
7Gy/F, d7, q3w, 5 cycles
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.
Tislelizumab
Tislelizumab 200 mg intravenous infusion on day 1 of each 21-day cycle for each of six cycles.
Interventions
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split-course HFRT
7Gy/F, d7, q3w, 5 cycles
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.
Tislelizumab
Tislelizumab 200 mg intravenous infusion on day 1 of each 21-day cycle for each of six cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Fujian Medical University Union Hospital
OTHER
Responsible Party
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Benhua Xu
Director
Principal Investigators
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Benhua Xu
Role: PRINCIPAL_INVESTIGATOR
Fujian Medical University Union Hospital
Locations
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Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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Benhua Xu
Role: primary
References
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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.
Other Identifiers
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FujianUnionH-HFRT
Identifier Type: -
Identifier Source: org_study_id
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