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Phase II Basket Trial: Zanidatamab Plus Tislelizumab in HER2-Positive GI Tumors (UNION-HER2-BASKET)

NCT07243938 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-11-24

No results posted yet for this study

Summary

This study is a prospective, multi-cohort clinical trial designed to evaluate the preliminary efficacy and safety of zanidatamab in combination with tislelizumab and chemotherapy/radiotherapy for patients with HER2-positive locally advanced or metastatic gastrointestinal tumors.

Conditions

  • Locally Advanced Rectal Cancer (LARC)
  • Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
  • Metastatic Colorectal Cancer (mCRC)
  • Neoadjuvant Therapy

Interventions

DRUG

Tisleizumab(BGB-A317)

200 mg，IV，D1，Q3W

DRUG

Capecitabine

1000mg/m2/time，BID，PO，D1-14, Q3W

DRUG

Oxaliplatin

130 mg/m2/次，IV，D1, Q3W

PROCEDURE

TME surgery

The surgery was performed 4 - 6 weeks after the end of neoadjuvant therapy in patients who assessed as non-cCR.

DRUG

S-1

40\~60mg bid，po, d1\~14，Q3W （S-1：BSA \<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA\>1.5m2, 60mg bid）

PROCEDURE

D2

Radical gastrectomy with D2 lymph node dissection was performed within 4-6 weeks after the completion of neoadjuvant therapy in patients without tumor progression on preoperative imaging assessment.

RADIATION

short-course radiotherapy

25Gy, 5Gy×5

DRUG

Zanidatamab

1800mg(\<70kg)/2400mg(≥70kg), IV，D1，Q3W

Sponsors & Collaborators

  • Tao Zhang

    lead OTHER

Principal Investigators

  • Tao Zhang, Ph.D. · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2028-07-30
Completion
2031-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07243938 on ClinicalTrials.gov