Radiotherapy Followed by Chemotherapy With Target Therapy and Anti-PD-1 Immunotherapy in Locally Advanced Rectal Cancer With Refractory Liver Metastasis/Pulmonary Metastasis(Miracle-2): A Prospective, Single Arm, Multi-Center, Phase II Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Advanced Rectal Cancer
- Sponsor
- LI XIN-XIANG
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Early Tumor Shrinkage
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
Though surgical resection remains the primary choice for advanced rectal cancer, about 80% are considered unresectable due to the number, size, or location of metastases. The overall prognosis of patients who accepted traditional treatment methods is still poor. Therefore, the investigators designed a combination therapy, short-course radiotherapy followed by chemotherapy with target therapy and anti-PD-1 immunotherapy. This study implement the combination therapy in patients with rectal cancer who are initially unresectable in the locally advanced stage with multiple liver/pulmonary metastases, to evaluate whether they can improve the objective response rate, the conversion rate of radical surgery and prolong the overall survival of patients, and strive to provide high-level medical evidence for the clinical treatment.
Investigators
LI XIN-XIANG
Professor
Fudan University
Eligibility Criteria
Inclusion Criteria
- •Age 18\~70;
- •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 multiple measurable metastases exist in the liver or lung , which are evaluated as NED unacceptable 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
Early Tumor Shrinkage
Time Frame: 5 years after intervention
The relative change of the sum of the longest diameters of the baseline RECIST target lesion at 8 weeks of systemic therapy, distinguished by 20% as the cut-off point between early response and no response.
Secondary Outcomes
- Overall Survival(5 years after intervention)
- Acute toxicity associated with immunotherapy(from the beginning of the treatment to 90 days after the end of immunotherapy)
- Duration of Response(5 years after intervention)
- Progression-Free Survival(5 years after intervention)
- Disease Control Rate(5 years after intervention)