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

C

China Medical University

Status and phase

Unknown
Phase 2

Conditions

HER2-positive Gastric Cancer

Treatments

Drug: Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur

Study type

Interventional

Funder types

Other

Identifiers

NCT05070598
Shengjing-LCG

Details and patient eligibility

About

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.);

Enrollment

35 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 1 patient group

Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur
Experimental group
Description:
Camrelizumab Q3W d1 Pyrotinib d1-21 Nab-paclitaxel Q3W d1 Tegafur d1-14
Treatment:
Drug: Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur

Trial contacts and locations

1

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Central trial contact

Nan Zhang, doctor; Nan Niu, doctor

Data sourced from clinicaltrials.gov

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