Status:
UNKNOWN
Camrelizumab Plus Apatinib as Maintenance Therapy in Extensive-stage Small-cell Lung Cancer
Lead Sponsor:
Henan Cancer Hospital
Conditions:
Small Cell Lung Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This single-arm, Phase II study was designed to evaluate the safety and efficacy of Camrelizumab (anti-programmed death-receptor 1 \[PD-1\] antibody) combination with Apatinib in participants with ES-...
Eligibility Criteria
Inclusion
- Male or female patients aged 18 and 75 years old;
- Signed the informed consent form prior to patient entry;
- Eastern Cooperative Oncology Group performance status of 0 or 1;
- Expected Survival Time: Over 3 months;
- Pathological or cytologically proven extensive-Stage small cell lung cancer(according to Veterans Administration Lung Study Group)and without progression after Cycles 4-6 21-day cycles of first-line Standard chemotherapy(Evaluation was CR /PR/SD based on RECIST1.1);
- If prophylactic cranial irradiation (PCI) was not planned,informed consent was required to be written between 3 weeks and 5 weeks after day 1 of the last cycle of chemotherapy. If PCI was planned or already performe, informed consent was required to be written between 3 weeks and 8 weeks after day 1 of the last cycle of chemotherapy.
Exclusion
- Has prior therapy with anti-programmed cell death (PD)-1, anti-PD-L1,anti Cytotoxic T lymphocyte-associated Antigen(CTLA)-4 or other Drugs that target T cells;
- Has prior therapy with angiogenesis inhibitors,Such as sunitinib, bevacizumab, apatinib, anlotinib;
- Has active or untreated central nervous system (CNS) metastases and/or cancerous meningitis;
- Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear;
- Has spinal cord compression which was not cured or relieved through surgery and/or radiotherapy, or diagnosed spinal cord compression after treatment showed no clinical evidence of disease stabilization prior to allocation ≥1 week;
- Within the past 2 weeks have used high dose antibiotics;
- According to the judgement of the researchers, there are other factors that may lead to the termination of the study.
Key Trial Info
Start Date :
July 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04901754
Start Date
July 14 2021
End Date
March 31 2023
Last Update
December 8 2021
Active Locations (1)
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1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000