SIB-RT Combined With CAPOX and PD-1 for High-Risk Rectal Cancer
NCT ID: NCT07297030
Last Updated: 2025-12-22
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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NOT_YET_RECRUITING
PHASE2
37 participants
INTERVENTIONAL
2025-12-20
2029-05-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SIB-SCRT+CAPOX+PD-1
Patients received neoadjuvant treatment consisting of SIB-SCRT ( PTV-GTV 31Gy/5F/6.2Gy) followed by sintilimab (3mg/kg intravenous drip on day 1; every 3-week cycle for two cycles) combined with CAPOX (oxaliplatin 130 mg/m2 intravenous infusion over 2 h on day 1, capecitabine 1000 mg/m2 orally twice daily from day 1-14, in every 3-week cycle for two cycles) 1 week later.
SIB-SCRT
The pelvic lymphatic drainage regions receive 25 Gy in 5 fractions (5 Gy per fraction). A ssequential boost to a total dose of 30 Gy in 6 fractions is delivered to the primary tumour and any radiologically suspicious lymph nodes.
CAPOX
* Oxaliplatin 130 mg/m² intravenously on day 1.
* Capecitabine 1,000 mg/m² orally twice daily on days 1-14.
Immunotherapy
\- Tislelizumab 200 mg intravenously on day 1.
Interventions
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SIB-SCRT
The pelvic lymphatic drainage regions receive 25 Gy in 5 fractions (5 Gy per fraction). A ssequential boost to a total dose of 30 Gy in 6 fractions is delivered to the primary tumour and any radiologically suspicious lymph nodes.
CAPOX
* Oxaliplatin 130 mg/m² intravenously on day 1.
* Capecitabine 1,000 mg/m² orally twice daily on days 1-14.
Immunotherapy
\- Tislelizumab 200 mg intravenously on day 1.
Eligibility Criteria
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Inclusion Criteria
* Age at the time of signing the informed consent form must be between 18 and 75 years.
* Histologically confirmed diagnosis of rectal adenocarcinoma.
* The inferior margin of the tumor must be ≤10 cm from the anal verge.
* No prior anti-cancer treatment for rectal cancer (including local-regional and systemic therapy).
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.
* At least one measurable lesion according to RECIST v1.1 criteria.
* Normal function of major organs without severe abnormalities in hematological, cardiovascular, pulmonary, hepatic, renal, or bone marrow function; laboratory tests must meet the following requirements:
Hemoglobin (Hb) ≥ 70 g/L; White blood cell count (WBC) ≥ 3.0 × 10\^9/L; Neutrophil count (NEUT) ≥ 1.5 × 10\^9/L; Platelet count (PLT) ≥ 100 × 10\^9/L; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times the upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); Renal function (serum creatinine, sCr) level ≤ 1.5 times the upper limit of normal (ULN).
Exclusion Criteria
* Recurrent rectal cancer.
* Documented allergy to the investigational drug and/or its excipients.
* Contraindications to radiotherapy and/or chemotherapy.
* Women who are pregnant or breastfeeding.
* A history of other malignancies.
* Patients who have participated in other clinical trials involving investigational drugs within the last 6 months.
* Patients deemed inappropriate for inclusion in this study as determined by the investigator.
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Yanhong Deng
M.D.
Locations
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Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Huang Liang MD, PhD
Role: primary
Other Identifiers
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GIHSYSU-38
Identifier Type: -
Identifier Source: org_study_id