Clinical Study of Albumin-paclitaxel Combined With Apatinib and Camrelizumab in Advanced Gastric Cancer

Sponsor
China Medical University, China
Study ID
NCT04286711
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Advanced Gastric Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Albumin-paclitaxel, Apatinib, Camrelizumab — DRUG
    Albumin-paclitaxel: ivgtt, 75 or 100 or 125mg /m2, d1, d8, Repeat the therapeutic schedule every 3 weeks; Apatinib: initial dose: 250mg,oral,once a day, after meal ( try to take the medicine at the same time each day); Camrelizumab：ivgtt, 200mg, given on the first day, Q3W;

Study Details

This study is to evaluate the tolerance of albumin paclitaxel combined with apatinib and Camrelizumab in the second-line treatment of advanced gastric cancer to determine the maximum tolerable dose (MTD) of the combination.

Key Dates

Start date
Mar 31, 2020
Status verified
Feb 2020
Primary completion
Aug 31, 2020
Completion
Jun 30, 2021

Study Design

Enrollment
52 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Albumin-paclitaxel Combined With Apatinib and Camrelizumab
    Albumin-paclitaxel: ivgtt, 75 or 100 or 125mg /m2, d1, d8; Apatinib: initial dose: 250mg,oral,once a day, after meal ( try to take the medicine at the same time each day); Camrelizumab：ivgtt, 200mg, given on the first day; Repeat the therapeutic schedule every 3 weeks

Primary Outcome Measure

Dose-Limiting Toxicity [DLT] [ Time Frame: Each 21 days up to Dose-Limiting Toxicity (12-13 months) ]

Central Contacts

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