Camrelizumab With Famitinib for Patients With Rare Head and Neck Malignancies

Conditions

• Head and Neck Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed

Jun 23, 2026

Start date

Jul 1, 2026

Status verified

Jun 2026

Primary completion

Jul 1, 2028

Completion

Jul 1, 2029

Study Design

Enrollment

40 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Camrelizumab With Famitinib
  camrelizumab 200 mg, IV, on Day 1, Q3W; famitinib 10 mg, PO, QD, Q3W, with 21 days constituting one treatment cycle

Primary Outcome Measure

Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: 12 months ]

Central Contacts

• Guoxin Ren, M.D.
  13916948812
  [email protected]

Find similar trials

Related Studies

• Identification and Characterization of Novel Proteins and Genes in Head and Neck Cancer
  Recruiting · Stanford University · Stanford, California
• Identification of Secreted Markers for Tumor Hypoxia in Patients With Head and Neck or Lung Cancers
  Recruiting · Stanford University · Stanford, California
• Tissue Sample Collection From Patients With Head and Neck Cancer and From Healthy Participants
  Recruiting · Vanderbilt University Medical Center · Nashville, Tennessee
• Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
  Recruiting · University of Colorado, Denver · Aurora, Colorado