Clinical trial · Observational
Chemotherapy and Tislelizumab With Split-course HFRT for Locally Advanced Rectal Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation Oncology | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAPOX chemotherapy | Drug | — | UNRESOLVED |
| split-course HFRT | Radiation | — | UNRESOLVED |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- HFRT with concurrent chemotherapy and immunotherapy
- description
- CAPOX chemotherapy plus tislelizumab treatment plus split-course HFRT
- interventionNames
- Radiation: split-course HFRT
- Drug: CAPOX chemotherapy
- Drug: Tislelizumab
Primary outcomes (1)
- measure
- pathological complete response(pCR)
- timeFrame
- 1 year
- description
- pCR is defined as no residual tumor in the surgical specimen.
Secondary outcomes (6)
- measure
- 3-year disease-free survival
- timeFrame
- 2 years
- description
- the time from randomization to disease recurrence or patient death due to disease progression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDZheng 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