A Combination Therapy Including Anti-PD-1 Immunotherapy in Rectal Cancer With Refractory Distal M… (NCT05359406) | Clinical Trial Compass
UnknownPhase 2
A Combination Therapy Including Anti-PD-1 Immunotherapy in Rectal Cancer With Refractory Distal Metastasis
China51 participantsStarted 2022-12-01
Plain-language 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.
Who can participate
Age range18 Years – 70 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;