Fudan University
l IX in-X Ian G
Although patients with locally advanced rectal cancer and resectable liver/pulmonary metastasis could benefit from surgery resection, these patients still have a poorer prognosis compared to those without distal metastasis. Based on previous studies, there is no confirmation of whether these patients could benefit from preoperative immunotherapy combined with conventional chemoradiotherapy. This study proposes a combination therapy, preoperative short-course radiotherapy followed by neoadjuvant chemotherapy and anti-PD-1 immunotherapy, for microsatellite-stable patients with locally advanced rectal cancer and resectable liver/pulmonary metastasis, to assess its impact on tumor retreat, decline of postoperative metastasis and recurrence, and the disease-free survival and overall survival of patients. Besides, this study will provide high-level medical evidence for future clinical treatment of patients with advanced rectal cancer.
Advanced Rectal Cancer
Liver Metastasis
Pulmonary Metastasis
Microsatellite Stable Colorectal Carcinoma
a combination therapy including tislelizumab
Phase 2
Study Type : | Interventional |
Estimated Enrollment : | 52 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | Radiotherapy Followed by Chemotherapy and Anti-PD-1 Immunotherapy in MSS Rectal Cancer With Resectable Liver/ Pulmonary Metastasis(Miracle-1): A Prospective, Single Arm, Multi-Center, Phase II Clinical Trial |
Actual Study Start Date : | December 1, 2022 |
Estimated Primary Completion Date : | September 1, 2027 |
Estimated Study Completion Date : | September 1, 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: resectable group In this group, we propose a combination therapy, preoperative short-course radiotherapy followed by neoadjuvant chemotherapy and anti-PD-1 immunotherapy, for microsatellite-stable patients with locally advanced rectal cancer and resectable liver/pulmonary metastasis. |
Combination Product: a combination therapy including tislelizumab |
Ages Eligible for Study: | 18 Years to 75 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
F Udanuniversity Shanghai cancer center
Shanghai, Shanghai, China, 200032