A Combination Therapy Including Anti-PD-1 Immunotherapy in MSS Rectal Cancer With Resectable Dist… (NCT05359393) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Combination Therapy Including Anti-PD-1 Immunotherapy in MSS Rectal Cancer With Resectable Distal Metastasis
China52 participantsStarted 2022-12-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Blood routine examination (no blood transfusion within 7 days before screening, no correction with hematopoietic stimulating factor drugs):
✓. Blood chemistry (no blood transfusion or albumin within 7 days prior to screening):
✓. TSH is within the normal range; if TSH is out of the normal range, FT3 and FT4 should be investigated. If the test results of FT3/FT4 cannot be obtained, T3 and T4 can be accepted. If the level of T3/T4 is normal, the patients can be selected.
✓. Urine test: urine protein\<2+; if the urine protein≥2+, the 24-hour urine protein quantification must be≤1g;
✕. 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;