NCT04006821

PD-1 Antibody + Apatinib Mesylate in 2+ Line Serum AFP-elevated Gastric Adenocarcinoma

PD-1 Antibody Combined With Apatinib Mesylate as 2+ Line Treatment of Serum AFP-elevated Gastric Adenocarcinoma: an Open-label, Single-arm, Multicenter Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: China Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of PD-1 antibody combined with apatinib mesylate in patients with unresectable, local advanced recurrent or metastatic serum AFP-elevated gastric adenocarcinoma, who have at least received first-line antitumor therapy or whose standard treatment is intolerable.

Detailed description

AFP-elevated gastric adenocarcinoma is a special type of gastric cancer, with the characteristics of high risk of liver and lymph node metastasis, poor therapeutic effect, and prognosis. This prospective study is a single-arm, open-label, multi-center phase II clinical trial to evaluate the efficacy and safety of PD-1 antibody combined with apatinib mesylate in patients with unresectable, local advanced recurrent or metastatic serum AFP-elevated gastric adenocarcinoma, who have at least received first-line antitumor therapy or whose standard treatment is intolerable. AFP elevation is defined as serum AFP \> 20 ng/ml. In this prospective study, the objective remission rate (ORR) will be used as primary outcome measures and 30 patients will be recruited. PD-1 antibody combined with apatinib mesylate will be administered. PD-L1 expression and TMB will be measured before treatment. In addition, the dynamic changes of serum AFP levels, T lymphocyte in peripheral blood will be monitored before each treatment cycle. In the course of treatment, safety evaluation will be carried out according to the standard of adverse reaction classification (CTCAE) 4.0.

Conditions

• Gastric Cancer
• AFP

Interventions

Type	Name	Description
DRUG	PD-1 antibody	Camrelizumab will be administered 200mg iv every 2 weeks until disease progression or lasts for two years.
DRUG	Apatinib mesylate	Apatinib mesylate will be administered 250mg or 500mg (according to the patient's tolerance), qd, oral, until disease progression.

Timeline

• Start date: 2019-07-25
• Primary completion: 2022-08-01
• Completion: 2022-08-01
• First posted: 2019-07-05
• Last updated: 2021-09-30

Locations

1 site across 1 country: China