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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Advanced Rectal Cancer
- Sponsor
- Fudan University
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- NED rate
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
LI XIN-XIANG
Professor
Fudan University
Eligibility Criteria
Inclusion Criteria
- •Age 18\~75;
- •Patient signs informed consent;
- •ECOG score 0\~1;
- •Initial colonoscopy and pathology: adenocarcinoma;
- •MRI: rectal cancer located less than 10cm from the anus;
- •Imaging confirms that there are measurable metastases in the liver or lung, which are evaluated as NED acceptable by MDT discussion;
- •no previous treatment;
- •Patients have adequate organ function;
- •No contraindications to surgery or chemoradiation;
- •The relevant test results within 7 days before the first dose must meet the following requirements:
Exclusion Criteria
- •Patients will not be accepted into this study if they meet any of the following criteria:
- •History of tumor-related disease and treatment:
- •Age \<18 or \>75 years;
- •other malignancy within 5 years, except adequately treated carcinoma in situ of the cervix or squamous cell carcinoma of the skin, or largely controlled basal cell carcinoma of the skin;
- •malignant pleural effusion or malignant ascites;
- •patients with severe medical comorbidities that preclude radiotherapy and surgery;
- •previously treated;
- •clinical or radiological evidence of spinal cord compression or a tumor within 3mm of the spinal cord on MRI
- •the presence of distant metastases besides the liver and lungs, including brain, bone, ovarian, peritoneal and retroperitoneal multiple lymph node metastases;
- •Patients who are considered suitable for using intense systemic treatment to achieve conversion after MDT discussion;
Outcomes
Primary Outcomes
NED rate
Time Frame: 1 years after treatment
rate of no evidence of disease for one year
Secondary Outcomes
- Disease Free Survival(5 years after surgery)
- Tumor Regression Rate(5 years after surgery)
- Acute toxicity associated with immunotherapy(from the beginning of treatment to 90 days after the end of immunotherapy)
- Objective Response Rate(5 years after surgery)
- Local Recurrence(5 years after surgery)
- Overall Survival(5 years after surgery)