MR-guided adaptive radiotherapy with immunotherapy for advanced rectal cancer
A Prospective, Randomized, Phase II Trial of MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer
This study is testing a new treatment that combines special radiation therapy, an immune therapy drug, and chemotherapy to see if it helps people with advanced rectal cancer respond better before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, Toripalimab |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06840665 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of MR-guided adaptive radiotherapy combined with the PD-1 antibody Toripalimab and the chemotherapy regimen CAPOX in patients with locally advanced rectal cancer. A total of 46 patients will receive this treatment approach, followed by total mesorectal excision surgery. The primary goal is to evaluate the rate of pathological complete response, while secondary outcomes include assessing adverse effects, anal function, and long-term survival rates.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with pathologically confirmed locally advanced rectal adenocarcinoma and no evidence of distant metastases.
Not a fit: Patients with a history of other malignancies, uncontrolled epilepsy, or psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the response rates and outcomes for patients with locally advanced rectal cancer.
How similar studies have performed: While there have been studies on adaptive radiotherapy and immunotherapy separately, this specific combination approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-70 years old, male or female 2. Pathologically confirmed rectal adenocarcinoma 3. The distance from anal verge ≤ 10 cm 4. Clinical stage T3-4 and/or N+ 5. No evidence of distance metastases 6. MSI/MMR status: MSS/pMMR 7. Karnofsky score \>=70 8. Adequate organ function and have no contraindications to surgery, radiochemotherapy, or immunotherapy 9. No chemotherapy or any other anti-tumor therapy prior to enrollment 10. No immunotherapy prior to enrollment 11. With good compliance during the study 12. Signed written informed consent Exclusion Criteria: 1. Known history of other malignancies within 5 years， except cured skin cancer and cervical cancer in situ 2. Pregnancy or breast-feeding women 3. Individuals with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders that, in the judgment of the investigator, are of such clinical severity that they may prevent the signing of an informed consent form or affect the patient's adherence to oral medications 4. Individuals with clinically serious (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months 5. Individuals with a history of organ transplantation requiring immunosuppressive therapy and long-term hormone therapy 6. Individuals with autoimmune diseases 7. Individuals with severe uncontrolled recurrent infections，or other severe uncontrolled concomitant diseases 8. Baseline hematology and biochemistry not meeting the following criteria: Hb≥90g/L; NEU ≥1.5×109/L; PLT ≥100×109/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; TB \<1.5 times the upper limit of normal; Cr \<1 time the upper limit of normal; Alb ≥30g/L 9. Individuals with dihydropyrimidine dehydrogenase (DPD) deficiency 10. Individuals allergic to any drug component of the study
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Zhen Zhang, MD
- Email: zhen_zhang@fudan.edu.cn
- Phone: +86 18017312217
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.