Actively Recruiting
Camrelizumab Plus Famitinib as Treatment in Patient With Advanced or Metastatic Pulmonary Sarcomatoid Carcinoma
Led by Qian Chu · Updated on 2024-10-01
28
Participants Needed
8
Research Sites
206 weeks
Total Duration
On this page
Sponsors
Q
Qian Chu
Lead Sponsor
J
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single arm, multi-center clinical trial. Target population is patients with Advanced or Metastatic Pulmonary Sarcomatoid Carcinoma，aiming to evaluate the efficacy and safety of the combination therapy of Camrelizumab and famitinib . Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody, and famitinib is an orally bioavailable receptor tyrosine kinase (RTK) inhibitor.
CONDITIONS
Official Title
Camrelizumab Plus Famitinib as Treatment in Patient With Advanced or Metastatic Pulmonary Sarcomatoid Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with stage IIIB, IIIC, or IV pulmonary sarcomatoid carcinoma or non-small cell lung cancer with sarcomatoid components
- No prior systemic therapy; neoadjuvant or adjuvant chemotherapy or radiotherapy allowed if recurrence or metastasis occurred more than 6 months after treatment
- At least one measurable tumor lesion according to RECIST 1.1
- ECOG performance status score of 0 or 1
- Willing to provide tumor tissue samples for biomarker tests
- Life expectancy greater than 3 months
- Adequate organ function
You will not qualify if you...
- Tumor invading major blood vessels or hemoptysis of 2.5 mL or more within 1 month before treatment
- Presence of EGFR-sensitive mutations, ALK, ROS1 rearrangements, BRAF V600E mutation, or MET exon 14 skipping mutation
- Active bleeding or bleeding tendency
- Uncontrolled hypertension despite medication (blood pressure over 140/90 mmHg)
- Urine protein levels 2+ or higher or 24-hour urine protein 1.0 g or more
- Blood clotting disorders requiring certain anticoagulant or antiplatelet therapies
- Conditions affecting oral drug absorption such as swallowing difficulties, nausea, vomiting, chronic diarrhea, or intestinal blockage
- Active central nervous system metastases
- Immunodeficiency or recent use (within 7 days) of systemic immunosuppressive therapy unrelated to tumor
- Active hepatitis B infection
- Severe infections within 4 weeks before treatment
- Pregnant or breastfeeding women
- Significant heart disease including ischemia, recent heart attack, poorly controlled arrhythmias, severe heart failure, or low left ventricular ejection fraction
- Known HIV infection
- Known allergy to Camrelizumab, Famitinib, or related components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
The first Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Active, Not Recruiting
2
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
3
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Actively Recruiting
4
Qian Chu
Wuhan, Hubei, China, 430000
Actively Recruiting
5
Hubei Cancer Hospital
Wuhan, Hubei, China
Actively Recruiting
6
Renmin Hospital of Wuhan University Hubei General Hospital
Wuhan, Hubei, China
Actively Recruiting
7
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
8
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
Active, Not Recruiting
Research Team
Q
Qian Chu
CONTACT
L
Lin Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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