Camrelizumab Combined With Chemotherapy in First-line Treatment of HER2-positive Gastric Cancer

Phase 2

• Conditions: HER2-positive Gastric Cancer
• Interventions: Drug: Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur

• Registration Number: NCT05070598
• Lead Sponsor: Shengjing Hospital

Brief Summary

According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety, or affect the patient's completion of the study (such as uncontrolled hypertension, diabetes, thyroid disease, etc.);

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study Start: 2021-09-07
• Study First Submitted: 2021-09-27
• Study First Submitted QC: 2021-09-27
• Last Update Submitted: 2021-09-27
• Study First Posted: 2021-10-07
• Last Update Posted: 2021-10-07
• Primary Completion: 2023-09-01
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• rious hepatic and renal impairment, organ function must meet the following requirements: ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L; Hb ≥ 90g/L; TBIL ≤ 1.5 × ULN; ALT and AST ≤1.5 × ULN, ALP ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN BUN and Cr ≤ 1 × ULN and cre

Exclusion Criteria

• rious hepatic and renal impairment, organ function must meet the following requirements: ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L; Hb ≥ 90g/L; TBIL ≤ 1.5 × ULN; ALT and AST ≤1.5 × ULN, ALP ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN BUN and Cr ≤ 1 × ULN and cre

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur	Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur	Camrelizumab Q3W d1 Pyrotinib d1-21 Nab-paclitaxel Q3W d1 Tegafur d1-14

Primary Outcome Measures

Name	Time	Method
ORR (Objective control rate)	up to 12 months	The rate of CR and PR, determined using RECIST v1.1 criteria

Secondary Outcome Measures

Name	Time	Method
PFS (Progression-Free survival)	up to 12 months	From the date Into this study (signed ICF) to tumor progression or death for any
OS(Overall survival)	up to approximately 24 months	Baseline until death from any cause
DCR (Disease control rate)	up to 12 months	The rate of CR, PR plus SD

Trial Locations

Locations (1)

Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, China