Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07685704
PHASE2

Zanidatamab Combined With Chemotherapy as Neoadjuvant/Conversion Therapy for HER2-Positive (IHC 3+ or IHC 2+) Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: a Phase II Open-Label Study

Sponsor: Zhifeng Zhao, PhD

View on ClinicalTrials.gov

Summary

This is a phase II open-label study to evaluate the efficacy and safety of zanidatamab combined with chemotherapy as neoadjuvant/conversion therapy in patients with HER2-positive (IHC 3+ or IHC 2+) locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma. The study consists of two cohorts: a neoadjuvant cohort (Simon's two-stage design, n=46) for treatment-naive stage III locally advanced disease, and an exploratory conversion cohort for oligometastatic disease. Patients receive zanidatamab (30 mg/kg Q3W) plus oxaliplatin-based chemotherapy, with or without PD-1 inhibitor (tislelizumab or sintilimab). The primary endpoint is pathological complete response (pCR).

Official title: A Phase II Open-Label Study Evaluating the Efficacy and Safety of Zanidatamab Combined With Chemotherapy as Neoadjuvant/Conversion Therapy in Patients With HER2-Positive (IHC 3+ or IHC 2+) Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2026-07

Completion Date

2028-12

Last Updated

2026-07-06

Healthy Volunteers

No

Interventions

DRUG

Zanidatamab

Zanidatamab injection, 300 mg/vial (manufacturer: Wuxi WuXi Biologics). Administered 30 mg/kg IV Q3W. Premedication (corticosteroids, antihistamines, antipyretics) 30-60 min before infusion. First two infusions over 120-150 min; subsequent may be shortened to 60-90 min if tolerated.

DRUG

Oxaliplatin

Oxaliplatin 130 mg/m2 IV infusion over \> 2 hours, D1 of each 21-day cycle. Administered after zanidatamab. Manufacturer not restricted.

DRUG

Capecitabine

Capecitabine 1000 mg/m2 PO BID, D1-14 of each 21-day cycle. Alternative to S-1 as part of CAPOX backbone.

DRUG

S-1

S-1 (Tegafur, Gimeracil, Oteracil) 40 mg/m2 PO BID, D1-14 of each 21-day cycle. Alternative to capecitabine as part of SOX backbone.

DRUG

Tislelizumab

Tislelizumab 200 mg Q3W IV. Alternatively, sintilimab 200 mg Q3W may be used at investigator's discretion. Conversion cohort only, for patients without immunotherapy contraindication.

Locations (1)

Xijing Hospital, Air Force Medical University

Xi'an, Shaanxi, China