Drug duo takes on rare head and neck tumors
NCT ID NCT07662681
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial investigates whether combining two drugs, camrelizumab and famitinib, can help people with rare head and neck cancers that have spread or cannot be removed by surgery. The study includes four types of these cancers and aims to see how safe and effective the treatment is. Participants receive the drugs in cycles, and the trial monitors side effects and how long they live or go without their cancer worsening.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- camrelizumab and famitinib
- What this could lead to
- If successful, this combination could offer a new treatment option for people with rare head and neck cancers that are hard to treat.
- What could go wrong
- This is an early-phase trial with only 40 participants, so results may not apply to everyone. Side effects from the drugs are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years; Histologically or cytologically confirmed unresectable or recurrent/metastatic soft tissue sarcoma, malignant melanoma, adenoid cystic carcinoma, or salivary gland carcinoma (non-adenoid cystic carcinoma) with no indication for curative treatment; Salivary gland tumors must be negative for both HER2 and AR, as determined by IHC; ECOG PS of 0-1; At least one measurable lesion according to RECIST v1.1 criteria; No prior PD-1 inhibitor therapy; Received ≤1 prior systemic therapy regimen; Adequate organ function, as defined by the following laboratory values: Organ Laboratory Value Hematology Absolute neutrophil count ≥1500/μL (1.5×10\^9/L) Platelets ≥100,000/μL (100×10\^9/L) Hemoglobin ≥9 g/dL (90 g/L) or ≥5.6 mmol/L Renal Creatinine or Creatinine clearance Creatinine ≤1.5×ULN; if creatinine \>1.5×ULN, then creatinine clearance ≥60 mL/min Hepatic Total bilirubin ≤1.5×ULN AST and ALT ≤2.5×ULN, or ≤5×ULN in the presence of liver metastases Coagulation INR or PT ≤1.5×ULN; for patients receiving anticoagulants, PT or PTT must be within the therapeutic range of the anticoagulant being used Female subjects must have a negative pregnancy test within 2 weeks prior to the start of study treatment and must not be breastfeeding. Female subjects must agree to use highly effective contraceptive measures during the study and for 6 months after the last dose of study drug. Male subjects must agree to use highly effective contraceptive measures during the study and for 6 months after the last dose of study drug; Subject voluntarily agrees to participate in the study, provides written informed consent, and is able to comply with the protocol-specified visits and related procedures. Exclusion Criteria: * Radiotherapy or other local therapy (e.g., surgery) within 2 weeks prior to enrollment, or failure to recover from adverse events of prior therapy (i.e., to ≤Grade 1 or baseline); Participation in a clinical trial within 4 weeks prior to enrollment; Poorly controlled cardiac symptoms or diseases, including: (1) NYHA Class II or higher heart failure or LVEF \<50% on echocardiography; (2) unstable angina; (3) myocardial infarction within 1 year prior to study treatment; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc \>450 ms (males) or QTc \>470 ms (females) (QTc interval calculated using the Fridericia formula; if QTc is abnormal, three consecutive measurements at 2-minute intervals may be taken and averaged). Hypertension that cannot be controlled to within the normal range with antihypertensive medication (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, based on the average of ≥2 BP readings); use of antihypertensive therapy to achieve these parameters is permitted. History of hypertensive crisis or hypertensive encephalopathy. Presence of multiple factors affecting oral drug absorption (e.g., inability to swallow, nausea and vomiting, chronic diarrhea, intestinal obstruction, etc.). Thrombotic or embolic events within 6 months prior to study treatment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc. Current interstitial pneumonitis or interstitial lung disease, or a history of interstitial pneumonitis or interstitial lung disease requiring corticosteroid therapy, or other conditions such as pulmonary fibrosis, organizing pneumonia, pneumoconiosis, drug-induced pneumonitis, or idiopathic pneumonitis that may interfere with the assessment and management of immune-related pulmonary toxicity, or evidence of active pneumonitis or severely impaired pulmonary function on chest CT at screening. Prior radiation pneumonitis in the radiation field is permitted; active tuberculosis. Investigator-assessed life expectancy of less than 3 months, or rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain, etc.); Abnormal coagulation function (INR \>1.5×ULN, APTT \>1.5×ULN) or bleeding tendency; Diagnosis of immunodeficiency within 7 days prior to enrollment, or receiving systemic corticosteroid therapy or other forms of immunosuppressive therapy. Diagnosis of other malignancies within 5 years prior to enrollment, except for cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, or other cured tumors that the investigator considers acceptable for exclusion. Known active central nervous system metastases; Tumor invasion of major blood vessels or tumor ulceration with bleeding, as judged by the investigator; Active autoimmune disease requiring systemic therapy within 2 years prior to enrollment; History of allogeneic tissue transplantation or solid organ transplantation; Active infection requiring systemic therapy; Psychiatric illness or substance abuse that would interfere with trial compliance or cooperation; Positive serology for HIV or a history of HIV infection; Active HBV or HCV infection; Receipt of a live vaccine within 30 days prior to the start of the trial. Other factors, such as medical history, that in the investigator's assessment could compromise subject safety or affect trial evaluations.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITINGShanghai, Shanghai Municipality, 200011, China
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