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Camrelizumab With Famitinib for Patients With Rare Head and Neck Malignancies
This is a prospective, multicenter, multi-cohort, Phase II clinical trial enrolling patients with unresectable, recurrent, or metastatic soft tissue sarcoma, malignant melanoma, adenoid cystic carcinoma, or salivary gland malignancies (excluding adenoid cystic carcinoma) who have not previously received PD-1 inhibitor therapy. The planned sample size is 10 subjects per cohort, for a total of 40 subjects. Investigators may adjust the cohort sample sizes based on actual enrollment. Potentially eligible subjects will be screened within 4 weeks prior to the first dose to assess their eligibility for study entry. Subjects confirmed by the investigator to meet all inclusion criteria and none of the exclusion criteria will receive the investigational medicinal products as per the study design and undergo efficacy and safety assessments. This trial will consist of three periods: Screening/Baseline Period, Treatment Period, and Follow-up Period. The study procedures include: Screening Period: From the signing of the informed consent form up to 28 days prior to the first dose; Treatment Period: Treatment discontinuation is defined as the cessation of treatment for any reason, such as disease progression or intolerance, or premature withdrawal for any reason; Follow-up Period: Following the subject's last dose, safety follow-up will be initiated to monitor the resolution of adverse events. The first safety follow-up visit will occur 30 ± 7 days after the last study dose (calculated based on the later date of 30 days post the last dose of either camrelizumab or famitinib). Subjects are required to return to the study center for this safety follow-up, regardless of whether they have initiated new antineoplastic therapy. The subsequent two safety visits (60 ± 7 days and 90 ± 7 days after the last dose) may be conducted via telephone. After study discontinuation, survival follow-up will be conducted every 3 months to monitor survival status and subsequent antineoplastic treatments
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