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

HER2-positive Gastric Cancer Clinical Trial

Official title:

A Prospective, Single-arm, Phase II Study of Camrelizumab Combined With Pyrotinib Maleate, Nab-paclitaxel and Tegafur Chemotherapy in First-line Treatment of HER2-positive Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05070598
• Other study ID #: Shengjing-LCG
• Status: Recruiting
• Phase: Phase 2
• Start date: September 7, 2021
• Est. completion date: March 30, 2024

Study information

• Verified date: September 2021
• Source: Shengjing Hospital
• Contact: Nan Zhang, doctor
• Phone: 18940253560
• Email: zhangnan2515[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.);

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: March 30, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HER2-positive Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur
Camrelizumab was given in the first day of each cycle,Nab-paclitaxel was given in the first day of each cycle, Pyrotinib was given everyday of each cycle, Tegafur given in the day 1-14 of each cycle

Locations

Country	Name	City	State
China	Shengjing Hospital of China Medical University	Shenyang

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR (Objective control rate)	The rate of CR and PR, determined using RECIST v1.1 criteria	up to 12 months
Secondary	DCR (Disease control rate)	The rate of CR, PR plus SD	up to 12 months
Secondary	PFS (Progression-Free survival)	From the date Into this study (signed ICF) to tumor progression or death for any	up to 12 months
Secondary	OS(Overall survival)	Baseline until death from any cause	up to approximately 24 months