Clinical Study of Camrelizumab Combined With APatinib and Albumin Paclitacxel in Patients With Advanced Lung Adenocarcinoma
- Sponsor
- Hunan Cancer Hospital
- Study ID
- NCT04459078
- Phase
- PHASE2
- Status
- Unknown
Conditions
- Adenocarcinoma of the Lung
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Camrelizumab — DRUGIntravenous administration of (200mg/3weeks)
- Albumin Paclitacxel — DRUGintravenous administration of Albumin Paclitacxel (135mg/m2, d1, d8/3w, 4-6 cycles)
- Apatinib — DRUGPatients will be given oral of Apatinib (250mg Qd po for 5 days, take rest for 2 days every week)
Study Details
This study is a single arm, open label, national multicenter study, to explore the efficacy and safety of the combination of Camrelizumab, apatinib and albumin paclitaxel in advanced untreated EGFR Wild Type and ALK-negative Lung Adenocarcinoma. The study does not consider PD-L1 expression, but tumor samples need to be explored by PD-L1 detection and other exploratory analysis.
Key Dates
- Start date
- Aug 26, 2020
- Status verified
- Nov 2022
- Primary completion
- May 15, 2023
- Completion
- Jul 15, 2023
Study Design
- Enrollment
- 63 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Camrelizumab combined with Albumin Paclitacxel and Apatinib.Participants are given intravenous administration of Camrelizumab (200mg/3w) in addition with intravenous administration of Albumin Paclitacxel (135mg/m2, d1, d8/3w, 4-6 cycles) and Apatinib (250mg Qd po for 5 days,, take rest for 2 days every week). Treatment terminates when disease progression, death or unacceptable toxicity.
Primary Outcome Measure
PFS [ Time Frame: Up to 24 months ]