Pyrotinib Plus Paclitaxel in the Second-Line Treatment of HER2-Amplified Advanced Gastric Cancer

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000035412

Enrollment

Unknown

Registered

2020-08-10

Start date

2020-09-01

Completion date

Unknown

Last updated

2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Gastric Cancer

Interventions

single arm:Pyrotinib Plus Paclitaxel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically proven adenocarcinoma of G/GEJ HER2 positivity (IHC3+ or ICH 2+ and HER2/CEP17 ratio greater than 2.0 on FISH) assessed before the first-line chemotherapy and refractory to fluoropyrimidine, platinum, and trastuzumab combination therapy. 2. Aged >=18 years; 3. Predicted life expectancy >=12 weeks; 4. Measurable and/or assessable lesions according to RECIST version 1.1; 5. ECOG PS 0-2; 6. Adequate bone marrow and organ function.

Exclusion criteria

Exclusion criteria: 1) Pregnancy or lactation; 2) Previously exposed to taxanes; 3) Had unresolved or unstable toxicity resulting from prior cancer treatment; 4) Had a history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure; 5) Exhibited hypersensitivity or idiosyncrasy to drugs chemically related to paclitaxel.

Design outcomes

Primary

Measure	Time frame
ORR;	—

Secondary

Measure	Time frame
PFS;OS;QoL;AE;	—

Countries

China

Contacts

Public ContactWang Chao-Jie

He'nan Provincial People's Hospital

zzwangcj@163.com+86 15981991266

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026