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Camrelizumab With Famitinib for Patients With Rare Head and Neck Malignancies

NCT07662681 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-06-23

No results posted yet for this study

Summary

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. The dosing regimen is as follows: camrelizumab 200 mg, IV, on Day 1, Q3W; famitinib 10 mg, PO, QD, Q3W, with 21 days constituting one treatment cycle. Study drugs should be administered at approximately the same time each day. If a patient vomits or misses a dose, no replacement dose should be taken on that day, and the next scheduled dose should be taken as usual. Subjects will continue treatment with camrelizumab and famitinib until discontinuation criteria are met. Clinical tumor imaging assessments will be performed every 2 cycles according to RECIST v1.1 (Appendix IV). Additionally, on Day 1 of each treatment cycle, clinically required assessments must be completed, including vital signs, physical examination, complete blood count, urinalysis, fecal occult blood test, hepatic and renal function tests, serum electrolytes, serum proteins, coagulation profile, serum tumor markers, thyroid function, electrocardiogram (ECG), and ECOG performance status score (specific assessments for each visit are detailed in the Schedule of Assessments). Hepatitis virus carriers will also require viral load monitoring every 2 to 4 treatment cycles.

Conditions

Interventions

DRUG

camrelizumab with famitinib

camrelizumab 200 mg, IV, on Day 1, Q3W; famitinib 10 mg, PO, QD, Q3W, with 21 days constituting one treatment cycle

Sponsors & Collaborators

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    lead OTHER

Principal Investigators

  • Yue He, M.D. · the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2028-07-01
Completion
2029-07-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07662681 on ClinicalTrials.gov