Comparing two types of radiotherapy for locally recurrent rectal cancer
Multicenter, Randomized, Phase II Trial of Neoadjuvant Hypofractionated Radiotherapy Plus Immunotherapy and First-line Therapy Versus Conventional Radiotherapy Plus First-line Therapy in pMMR Locally Recurrent Rectal Cancer (TORCH-R2)
This study is testing if a new type of radiotherapy combined with immunotherapy can help people with locally recurrent rectal cancer live longer without their cancer getting worse compared to standard radiotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 221 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, sintilimab |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06928584 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of hypofractionated radiotherapy combined with immunotherapy against conventional radiotherapy in patients with locally recurrent rectal cancer. Participants aged 18 to 75 with confirmed pelvic recurrence and no distant metastases will be randomized into two treatment groups. The experimental group will receive hypofractionated radiotherapy along with sintilimab and chemotherapy, while the control group will receive conventional radiotherapy and chemotherapy. The primary goal is to assess progression-free survival, with secondary goals including response rates and surgical outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with pelvic recurrence of rectal cancer and an ECOG performance status of 0-1.
Not a fit: Patients with distant metastases or those who have received prior radiotherapy or first-line chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and survival rates for patients with locally recurrent rectal cancer.
How similar studies have performed: Other studies have shown promise with hypofractionated radiotherapy and immunotherapy, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patient is 18-75 years. ECOG performance status 0-1. MRI/enhanced CT confirmed pelvic recurrence. Without synchronous distant metastases. No prior radiotherapy within 6 month. No prior first-line chemotherapy. Has an investigator determined life expectancy of at least 24 weeks. Demonstrate adequate organ function. Non pregnant or lactating patients. Fully informed and willing to provide written informed consent for the trial. Exclusion Criteria: Neutrophil\< 1.5×109/L, PLT\< 100×109/L (PLT\< 80×109/L in patients with livermetastasis), or Hb\< 90 g/L. TBIL \> 1.5 ULN, or TBIL \> 2.5 ULN in patients with liver metastasis. AST or ALT \> 2.5 ULN, or ALT and/or AST \> 5 ULN in patients with liver metastasis. Cr \> 1.5 ULN, or creatinine clearance\< 50 mL/min (calculated according to Cockcroft Gault formula). APTT \> 1.5 ULN, PT \> 1.5 ULN (subject to the normal value of the clinical trial research center). Serious electrolyte abnormalities. Urinary protein ≥ 2+, or 24-h urine protein ≥1.0 g/24 h. Uncontrolled hypertension: SBP \>140 mmHg or DBP \> 90 mmHg. A history of arterial thrombosis or deep vein thrombosis within 6 months; a history of bleeding or evidence of bleeding tendency within 2 months. A history of heart disease within 6 months. Uncontrolled malignant pleural effusion, ascites, or pericardial effusion. History of checkpoint inhibitor therapy. The presence of a clinically detectable second primary malignancy, or history of other malignancies within 5 years. A history of liver disease including, but not limited to, HBV infection or HBV DNA positive (≥1×104/mL), HCV infection or HCV DNA positive (≥1×103/mL), and liver cirrhosis. Pregnant or lactating women or women who may be pregnant have a positive pregnancy test before the first medication, or the female participants themselves and their partners who were unwilling to implement strict contraception during the study period. The investigator considers that the subject is not suitable to participate in this clinical study due to any clinical or laboratory abnormalities or compliance problems. Serious mental abnormalities. The diameter of brain metastasis is greater than 3 cm or the total volume is greater than 30 cc. Clinical or radiological evidence of spinal cord compression, or tumors within 3 mm of the spinal cord on MRI.
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Zhen Zhang, MD PhD, PhD — Fudan University
- Study coordinator: Zhen Zhang, MD, PhD
- Email: zhen_zhang@fudan.edu.cn
- Phone: 86-18801735029
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.