Camrelizumab, Apatinib and Nab-paclitaxel as Second-line Treatment in Advanced Gastric Cancer

Sponsor
Chinese PLA General Hospital
Study ID
NCT04182724
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Advanced Gastric Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab, Apatinib and Nab-paclitaxel — DRUG
    Camrelizumab was administered 200mg iv every 2 weeks, Apatinib was administered 250 mg p.o. qd Nab-paclitaxel was administered 125 mg/m2, 150 mg/m2, 175 mg/m2 or 200 mg/m2, iv. q2w

Study Details

This is a Phase I/II , Open-label , Investigator-initiated Trail of Camrelizumab (an Anti-PD-1 Inhibitor), Apatinib (VEGFR2 Inhibitor) and Nab-paclitaxel as Second-line Treatment in Advanced Gastric Cancer The study was designed in two stages, the first stage was the tolerance observation stage, and the second stage was the curative effect expansion stage. The first part of the study is the Dose-finding Phase designed to establish the safety of Camrelizumab, Apatinib and Nab-paclitaxel at different dose Levels(125 mg/m2, iv. q2w, 150 mg/m2, iv. q2w, 175 mg/m2, iv. q2w or 200 mg/m2, iv. q2w). The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses . This study aims to evaluate the safety and efficacy of Camrelizumab, Apatinib and Nab-paclitaxel in the Second-line treatment of advanced Gastric Cancer.

Key Dates

Start date
Nov 12, 2019
Status verified
Dec 2019
Primary completion
May 12, 2021
Completion
May 12, 2022

Study Design

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

Arms

  • Experimental: Camrelizumab, Apatinib and Nab-paclitaxel
    Camrelizumab was administered 200mg iv every 2 weeks, Apatinib 250 mg p.o. qd Nab-paclitaxel 125 mg/m2, 150 mg/m2, 175 mg/m2 or 200 mg/m2, iv. q2w

Primary Outcome Measure

MTD /DLT (phase I) [ Time Frame: Within four weeks after administration ]

Central Contacts

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