Combining chemotherapy and immunotherapy with targeted radiation for 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
This study is testing whether combining chemotherapy, immunotherapy, and targeted radiation can help people with advanced rectal cancer live longer and feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fujian Medical University Union Hospital Academic / other |
| Drugs / interventions | chemotherapy, tislelizumab, immunotherapy |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT05176964 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of combining chemotherapy, immunotherapy with tislelizumab, and split-course hypofraction radiotherapy (HFRT) in patients with locally advanced rectal cancer (LARC). The goal is to optimize the timing and administration of these treatments to improve patient outcomes. The study will analyze various clinical data using statistical methods to compare overall survival (OS) and progression-free survival (PFS) among participants. By assessing the interactions between these therapies, the study aims to provide insights into better treatment strategies for LARC.
Who should consider this trial
Good fit: Ideal candidates are treatment-naïve adults aged 18-70 with operable locally advanced rectal adenocarcinoma.
Not a fit: Patients over 70 years old, those with recurrent or metastatic disease, or individuals with severe organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and better treatment outcomes for patients with locally advanced rectal cancer.
How similar studies have performed: While similar approaches have been explored, this specific combination of therapies in the context of locally advanced rectal cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Fuzhou, Fujian
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Principal investigator: Benhua Xu — Fujian Medical University Union Hospital
- Study coordinator: Benhua Xu
- Email: benhuaxu@163.com
- Phone: 86+13696884375
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.