Camrelizumab Plus Famitinib as Treatment in Patient With Advanced or Metastatic Pulmonary Sarcomatoid Carcinoma
NCT ID: NCT04888429
Last Updated: 2024-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
28 participants
INTERVENTIONAL
2021-07-19
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Camrelizumab + Famitinib
Patients received camrelizumab 200 mg every 3 weeks and famitinib 20 mg once per day.
Camrelizumab
Patients received camrelizumab 200 mg every 3 weeks
Famitinib
Patients received Famitinib 20 mg once per day
Interventions
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Camrelizumab
Patients received camrelizumab 200 mg every 3 weeks
Famitinib
Patients received Famitinib 20 mg once per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has no prior systemic therapy; (chemotherapy and/or radiotherapy is allowed as part of neoadjuvant/adjuvant therapy. Patients who have had recurrence or metastasis for more than 6 months from the end of neoadjuvant/adjuvant treatment would be enrolled ) ；
* Patients must have at least one measurable lesion according to RECIST 1.1 ；
* ECOG score 0-1 ；
* Agree to provide tumour tissue samples for biomarker exploration (including but not limited to PD-L1 IHC or NGS testing) ；
* Life expectancy more than 3 months;
* Has adequate organ function；
Exclusion Criteria
* Patients with EGFR-sensitive mutation (19Exondel/L858R), ALK, ROS1 gene rearrangement or fusion, BRAFV600E mutation, MET gene exon 14 skipping mutation;
* Patients with active bleeding or bleeding tendency ；
* With hypertension that cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure ≤ 140 mmHg/diastolic blood pressure ≤ 90 mmHg)；
* Urine protein ≥ (+ +), and 24-hour urine protein ≥ 1.0g;
* Presence of thrombotic disorder requiring anticoagulant therapy with warfarin or heparin, or requiring antiplatelet therapy (aspirin ≥ 300 mg/day or clopidogrel ≥ 75 mg/day) ；
* Has multiple factors affecting the absorption of oral drugs, such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction
* Has active central nervous system (CNS) metastases confirmed by CT or MRI
* Subjects diagnosed immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy of non-related tumor within 7 days before the first dose; allowed physiological dose of glucocorticoid (≤10 mg/day Prednisone or equivalent);
* Has active hepatitis B ;
* Has severe infections within 4 weeks of the first dose of study treatment ;
* Women who are pregnant or lactating ;
* With grade II or above myocardial ischemia or myocardial infarction and poorly controlled arrhythmias (QTc interval ≥ 450 ms for males and QTc interval ≥ 470 ms for females). Subjects with grade III-IV cardiac insufficiency or with left ventricular ejection fraction (LVEF) less than 50% according to NYHA criteria;
* Has known history of Human Immunodeficiency Virus (HIV)；
* Has known allergy to Camrelizumab, or famitinib or any of accessories ;
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Qian Chu
OTHER
Responsible Party
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Qian Chu
Professor
Principal Investigators
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Qian Chu
Role: PRINCIPAL_INVESTIGATOR
Tongji Hospital
Lin Wu
Role: PRINCIPAL_INVESTIGATOR
Hunan Cancer Hospital
Locations
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The first Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Qian Chu
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Renmin Hospital of Wuhan University Hubei General Hospital
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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S037
Identifier Type: -
Identifier Source: org_study_id
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