Status:
UNKNOWN
A Trial of Camrelizumab for Injection in Combination With Famitinib Malate Capsule and Paclitaxel For Injection(Albumin Bound) in Advanced Solid Tumors of Patients
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The study is being conducted to evaluate safety, tolerability and preliminary efficacy of Camrelizumab for Injection in combination with Famitinib malate capsule and Paclitaxel For Injection(Albumin B...
Eligibility Criteria
Inclusion
- Male or female aged ≥18 years and ≤75 years at the time of signing the ICF;
- Dose Escalation Period: Histopathologically documented incurable advanced malignancies with standard treatment failure;
- At least one measurable lesion that meets RECIST 1.1 criteria in case of solid tumors;
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
- Life expectancy ≥3 months;
- Adequate organ functions as defined;
- Ability to understand and voluntarily agrees to participate by giving written informed consent for the study.
Exclusion
- The imaging examinations shows the tumor invades large blood vessels; Or as the assessment of the investigator, the tumor is highly likely to invade important blood vessels which would cause fatal bleeding during treatment;
- The imaging examinations shows significant pulmonary cavitary tumors occurs with the bleeding risk as the investigator's assessment;
- patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, or spinal cord compression;
- Uncontrollable pleural effusion, pericardial effusion or peritoneal effusion, with clinical symptoms;
- Severe bong injury caused by metastatic tumor of bone;
- Prior malignancy (other than current malignant tumor) within 3 years before the first dose of study treatment;
- History of autoimmune diseases;
- Evidence or history of arterial/venous thrombosis within 6 months before the first dose;
- Patients with interstitial pneumonitis or interstitial lung disease; past history of interstitial pneumonitis or interstitial lung disease requiring hormone therapy;
- When receiving immune checkpoint inhibitors previously, myocarditis related with immune, ≥ grade 2 of pneumonia related with immune or ≥ grade 3 of other adverse reactions related with immune occurred.
Key Trial Info
Start Date :
August 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2023
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05214976
Start Date
August 12 2022
End Date
July 31 2023
Last Update
December 22 2022
Active Locations (1)
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1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030