NCT05359393

A Combination Therapy Including Anti-PD-1 Immunotherapy in MSS Rectal Cancer With Resectable Distal Metastasis

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced Rectal Cancer
• Liver Metastasis
• Pulmonary Metastasis
• Microsatellite Stable Colorectal Carcinoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	a combination therapy including tislelizumab	Patients will receive tislelizumab in combination with neoadjuvant radiotherapy and chemotherapy, and will be evaluated 2-3 weeks after completion of the treatment. Those patients who achieve complete clinical regression of the lesion can choose observation, but for those without CCR, surgical resection (TME of the primary lesion, surgical resection of metastases or other destructive local treatment) will be applied. Patients will continue to receive tislelizumab for one year after surgery or during observation. For liver/pulmonary metastasis, the treatment plan is to implement large fraction radiotherapy for 4-8 times. For primary rectum lesion, short-course radiotherapy regimen through intensity-modulated radiotherapy will be applied with dose of 25Gy/5Fx. Immunotherapy contains anti-PD-1 monoclonal antibody, Tislelizumab(200mg, d1, q3w x6, i.v). Chemotherapy adopts CAPEOX plan, including Capecitabine(1000mg/m2 bid, d1-14, p.o) and oxaliplatin(130mg/m2, d1, i.v).

Timeline

• Start date: 2022-12-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2022-05-03
• Last updated: 2022-11-14

Locations

1 site across 1 country: China