Gastric CancerPhase 2NCT07685704
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
A Phase 2 study testing Zanidatamab, Oxaliplatin and Capecitabine in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by Zhifeng Zhao, PhD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, HER2-positive Gastric Cancer
- What is being tested?
- Zanidatamab, Oxaliplatin and Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- Jul 2026to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent (ICF).
- Histologically and radiologically (CT/MRI) confirmed gastric or gastroesophageal junction adenocarcinoma.
- Neoadjuvant cohort: Clinical stage III (cT3-4aN+M0) or locally advanced unresectable (cT4bNany M0) assessed by MDT as not amenable to R0 resection, or technically resectable but with high-risk factors (e.g., bulky nodal fusion, invasion of critical structures).
- Conversion cohort: Not amenable to direct surgery (e.g., invasion of adjacent organs or vessels) or with distant metastases, including liver metastases (C-GCLM type I and II), confirmed retroperitoneal lymph node metastases, or other single-organ metastases.
- HER2-positive by IHC (3+; or 2+ with FISH testing). No time window restriction on FISH.
- Age 18-75 years, male or female.
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- ECOG performance status 0-1; no contraindication to surgery.
- Adequate organ function for successful abdominal surgery.
- Life expectancy >= 3 months.
- Laboratory parameters within 7 days before enrollment:
- WBC > 4.0 x 10^9/L and < 15 x 10^9/L; ANC > 1.5 x 10^9/L; Hb >= 90 g/L; PLT >= 100 x 10^9/L.
- Total bilirubin <= 1.5 x ULN; AST and ALT <= 2.5 x ULN.
- Creatinine <= 1.5 x ULN, or CrCl > 60 mL/min (Cockcroft-Gault).
- No anticoagulation: INR and aPTT <= 1.5 x ULN. On stable anticoagulation: maintain stable dose.
- Good compliance; able to complete protocol-specified examinations and specimen collection.
- Female patients of childbearing potential must agree to contraception from ICF signing through at least 5 months after last dose and refrain from breastfeeding. Male patients must agree to contraception from first dose through at least 7 months after last dose.
Who cannot join
- Synchronous or metachronous malignancies of other organs, or recurrent disease.
- Prior systemic therapy for gastric cancer (neoadjuvant cohort).
- History of malignancy within 5 years before screening, except those with > 90% 5-year overall survival.
- Significant cardiopulmonary dysfunction.
- Major surgery within 4 weeks before study treatment initiation, or anticipated major surgery during study period (excluding diagnostic procedures).
- Severe infection within 4 weeks before study treatment initiation.
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- Prior chemotherapy or molecular targeted therapy (neoadjuvant cohort).
- Known hypersensitivity to study drugs or excipients, or history of severe allergic reactions to monoclonal antibodies.
- Factors affecting oral medication intake (e.g., dysphagia >= grade 2, chronic diarrhea).
- Significant uncontrolled comorbidities that may affect protocol compliance or interpretation of outcomes.
- Pregnancy or breastfeeding, or planning pregnancy during the study.
- Diagnosis of immunodeficiency or receiving systemic corticosteroid (> 10 mg/day prednisone equivalent) or other immunosuppressive therapy within 2 weeks before first dose.
- Active hepatitis B (HBV DNA >= 1 x 10^3 copies/mL or >= 200 IU/mL), positive anti-HCV, or positive HIV.
- Participation in another anti-tumor clinical trial within 28 days before first dose.
- Any condition that in the investigator's judgment may lead to premature study termination (e.g., serious illness including psychiatric disorders requiring concomitant treatment, severe laboratory abnormalities, family/social factors affecting subject safety or data collection).
- Patient or family refusal to sign informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xijing Hospital, Air Force Medical University
Xi'an, Shaanxi
Jianjun Yang, +86-13572533693
About this study
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
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).
Read the detailed description
Background:
HER2 overexpression (IHC 3+ or IHC 2+) occurs in approximately 12-20% of gastric and gastroesophageal junction adenocarcinomas. While perioperative trastuzumab-based regimens have shown promising pathological responses (pCR rates of 9.6% in NEOHX, 21.4% in HER-FLOT, 35% in PETRARCA), there remains an unmet need for more effective HER2-directed therapies in the neoadjuvant/conversion setting, particularly for IHC 2+ patients whose in situ hybridization testing rates are low in real-world practice.
Zanidatamab is a humanized bispecific IgG1-like antibody targeting two distinct HER2 epitopes (ECD4 and ECD2), demonstrating unique mechanisms including enhanced receptor clustering, complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and superior in vivo antitumor activity compared to trastuzumab plus pertuzumab. In a phase II study (NCT03929666), zanidatamab combined with chemotherapy as first-line treatment for HER2-positive advanced gastroesophageal adenocarcinoma achieved a confirmed objective response rate of 76.2%, median progression-free survival of 12.5 months, and median overall survival of 36.5 months, with manageable safety.
Study Design:
This is an investigator-initiated, phase II, open-label, two-cohort study. Neoadjuvant Cohort: Treatment-naive patients with stage III locally advanced gastric/gastroesophageal junction adenocarcinoma (cT3-4aN+M0, or cT4bNany M0 not amenable to R0 resection as assessed by MDT, or technically resectable but with high-risk factors such as bulky nodal fusion or invasion of critical structures) receive 3 cycles of zanidatamab (30 mg/kg Q3W) plus oxaliplatin-based chemotherapy (SOX or CAPOX per 2025 CSCO guidelines), followed by D2 radical gastrectomy 4-6 weeks after treatment completion. This cohort uses a Simon's two-stage design with a planned enrollment of 46 patients (H0: pCR <= 9.6%, H1: pCR >= 25%, one-sided alpha=0.05, power=80%). If <=2 pCRs among the first 17 patients, study terminates for futility; if >=7 pCRs among all 46, superiority over historical control is declared.
Conversion Cohort (Exploratory): Patients with oligometastatic disease (M1, <=2 organs, <=5 total metastatic lesions), including liver metastases (C-GCLM type I and II), confirmed retroperitoneal lymph node metastases, or other single-organ metastases, deemed potentially resectable by MDT, receive zanidatamab (30 mg/kg Q3W) plus oxaliplatin-based chemotherapy, with tislelizumab (200 mg Q3W, or sintilimab 200 mg Q3W) for patients without immunotherapy contraindications. Treatment continues up to 8 cycles with tumor assessment every 3 cycles; surgery timing at investigator's discretion.
Adjuvant therapy: For the neoadjuvant cohort, adjuvant therapy (4-5 cycles starting 4-6 weeks post-surgery) may be administered at the investigator's discretion. Total perioperative treatment duration should not exceed 8 cycles. Conversion cohort adjuvant therapy is at the investigator's discretion.
Endpoints: Primary endpoint is pathological complete response (pCR, ypT0N0). Secondary endpoints include MPR, R0 resection rate, down-staging rate, NCCN TRG 0/1, RFS, OS, treatment completion rate, and safety (CTCAE v5.0). Conversion cohort additionally evaluates ORR (RECIST v1.1, with iRECIST for pseudoprogression), PFS, and surgical conversion rate.
- Being tested
- Zanidatamab, Oxaliplatin, Capecitabine, S-1, Tislelizumab
- Keywords
- zanidatamab, HER2, neoadjuvant therapy, conversion therapy, gastric cancer, gastroesophageal junction adenocarcinoma, bispecific antibody
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanidatamabDrug
Also called ZIIHERA
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.
OxaliplatinDrug
Also called Eloxatin
Oxaliplatin 130 mg/m2 IV infusion over > 2 hours, D1 of each 21-day cycle. Administered after zanidatamab. Manufacturer not restricted.
CapecitabineDrug
Also called Xeloda
Capecitabine 1000 mg/m2 PO BID, D1-14 of each 21-day cycle. Alternative to S-1 as part of CAPOX backbone.
S-1Drug
Also called Teysuno
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.
TislelizumabDrug
Also called BGB-A317
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.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Cohort: Zanidatamab + Chemotherapy | Experimental | Patients with previously untreated stage III locally advanced gastric/gastroesophageal junction adenocarcinoma (cT3-4aN+M0, or cT4bNany M0 not amenable to R0 resection per MDT assessment) receive 3 cycles of zanidatamab (30 mg/kg Q3W) plus oxaliplatin-based chemotherapy (SOX: oxaliplatin 130 mg/m2 IV D1 + S-1 40 mg/m2 PO BID D1-14, Q3W; or CAPOX: oxaliplatin 130 mg/m2 IV D1 + capecitabine 1000 mg/m2 PO BID D1-14, Q3W), followed by D2 radical gastrectomy 4-6 weeks after treatment. Simon's two-stage design: n=46, H0 pCR <= 9.6%, H1 pCR >= 25%, one-sided alpha=0.05, power=80%. Receives: Drug: Zanidatamab; Drug: Oxaliplatin; Drug: Capecitabine; Drug: S-1 |
| Conversion Cohort: Zanidatamab + Chemotherapy +/- PD-1 Inhibitor | Experimental | Patients with oligometastatic disease (M1, <=2 organs, <=5 total lesions, including liver metastases C-GCLM type I/II, retroperitoneal lymph node metastases, or other single-organ metastases) deemed potentially resectable by MDT receive zanidatamab (30 mg/kg Q3W) plus oxaliplatin-based chemotherapy, plus tislelizumab (200 mg Q3W) or sintilimab (200 mg Q3W) if no immunotherapy contraindication. Up to 8 cycles, tumor assessment every 3 cycles. Exploratory cohort; no sample size calculation. Receives: Drug: Zanidatamab; Drug: Oxaliplatin; Drug: Capecitabine; Drug: S-1; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
pCR is defined as the absence of residual tumor cells in the primary tumor and all resected lymph nodes (ypT0N0) after neoadjuvant treatment, assessed by histopathological evaluation of surgical specimens.
Measured: At the time of surgery, approximately 4-6 weeks after completion of 3 cycles of neoadjuvant treatment (each cycle is 21 days)
Secondary outcomes (11)
Major Pathological Response (MPR)
MPR is defined as residual tumor cells <= 10% in the primary tumor bed and resected lymph nodes after neoadjuvant treatment.
Measured: At the time of surgery, approximately 4-6 weeks after completion of neoadjuvant treatment
R0 Resection Rate
R0 resection is defined as microscopically complete tumor removal with all margins negative on histopathological examination.
Measured: At the time of surgery, approximately 4-6 weeks after completion of neoadjuvant treatment
Down-Staging Rate
Down-staging is defined as any decrease in pathological T stage or N stage compared to pretreatment clinical stage (cTNM).
Measured: At the time of surgery, approximately 4-6 weeks after completion of neoadjuvant treatment
Tumor Regression Grade 0/1 Rate (NCCN TRG)
Proportion of patients achieving complete (TRG 0, no residual tumor) or near-complete (TRG 1, minimal residual tumor cells) pathological response per NCCN TRG criteria.
Measured: At the time of surgery, approximately 4-6 weeks after completion of neoadjuvant treatment
Recurrence-Free Survival (RFS)
Time from complete response after neoadjuvant/conversion therapy to tumor recurrence or death from any cause. DFS and EFS are considered equivalent to RFS.
Measured: From date of complete response after treatment until date of recurrence or death, assessed up to 60 months
Overall Survival (OS)
Measured: From date of enrollment until date of death from any cause, assessed up to 36 months
Objective Response Rate (ORR) - Conversion Cohort
Proportion of patients achieving CR or PR per RECIST v1.1. For suspected pseudoprogression, iRECIST used for confirmation.
Measured: Every 3 cycles during conversion treatment (up to 8 cycles, each cycle is 21 days), assessed per RECIST v1.1
Progression-Free Survival (PFS) - Conversion Cohort
Measured: From date of enrollment until date of disease progression or death, assessed up to 36 months
Neoadjuvant Treatment Completion Rate
Proportion of patients in the neoadjuvant cohort who complete all 3 planned cycles and proceed to surgery as scheduled.
Measured: At the end of neoadjuvant treatment period, approximately 9 weeks (3 cycles of 21 days each)
Surgical Conversion Rate - Conversion Cohort
Proportion of patients initially deemed unresectable who successfully undergo R0 resection after conversion therapy.
Measured: During conversion treatment period, up to 8 cycles (each cycle is 21 days)
Incidence of Treatment-Emergent Adverse Events
Adverse events assessed by NCI CTCAE v5.0, including incidence and severity of AEs, SAEs, and postoperative complications within 30 days (Clavien-Dindo classification).
Measured: From first dose through 30 days after last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhifeng Zhao, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhifeng Zhao, PhD, Xijing Hospital of Digestive Diseases
- Investigators
- Jianjun Yang, Prof., Principal investigator, Department of Digestive Surgery, Xijing Hospital, Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685704
- Sponsor's protocol ID
- KY20252609-F-1
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07685704
- Acronym / sponsor ID
- KY20252609-F-1
- Keywords
- zanidatamab, HER2, neoadjuvant therapy, conversion therapy, gastric cancer, gastroesophageal junction adenocarcinoma, bispecific antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Zhifeng Zhao, PhDUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Background:
HER2 overexpression (IHC 3+ or IHC 2+) occurs in approximately 12-20% of gastric and gastroesophageal junction adenocarcinomas. While perioperative trastuzumab-based regimens have shown promising pathological responses (pCR rates of 9.6% in NEOHX, 21.4% in HER-FLOT, 35% in PETRARCA), there remains an unmet need for more effective HER2-directed therapies in the neoadjuvant/conversion setting, particularly for IHC 2+ patients whose in situ hybridization testing rates are low in real-world practice.
Zanidatamab is a humanized bispecific IgG1-like antibody targeting two distinct HER2 epitopes (ECD4 and ECD2), demonstrating unique mechanisms including enhanced receptor clustering, complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and superior in vivo antitumor activity compared to trastuzumab plus pertuzumab. In a phase II study (NCT03929666), zanidatamab combined with chemotherapy as first-line treatment for HER2-positive advanced gastroesophageal adenocarcinoma achieved a confirmed objective response rate of 76.2%, median progression-free survival of 12.5 months, and median overall survival of 36.5 months, with manageable safety.
Study Design:
This is an investigator-initiated, phase II, open-label, two-cohort study. Neoadjuvant Cohort: Treatment-naive patients with stage III locally advanced gastric/gastroesophageal junction adenocarcinoma (cT3-4aN+M0, or cT4bNany M0 not amenable to R0 resection as assessed by MDT, or technically resectable but with high-risk factors such as bulky nodal fusion or invasion of critical structures) receive 3 cycles of zanidatamab (30 mg/kg Q3W) plus oxaliplatin-based chemotherapy (SOX or CAPOX per 2025 CSCO guidelines), followed by D2 radical gastrectomy 4-6 weeks after treatment completion. This cohort uses a Simon's two-stage design with a planned enrollment of 46 patients (H0: pCR <= 9.6%, H1: pCR >= 25%, one-sided alpha=0.05, power=80%). If <=2 pCRs among the first 17 patients, study terminates for futility; if >=7 pCRs among all 46, superiority over historical control is declared.
Conversion Cohort (Exploratory): Patients with oligometastatic disease (M1, <=2 organs, <=5 total metastatic lesions), including liver metastases (C-GCLM type I and II), confirmed retroperitoneal lymph node metastases, or other single-organ metastases, deemed potentially resectable by MDT, receive zanidatamab (30 mg/kg Q3W) plus oxaliplatin-based chemotherapy, with tislelizumab (200 mg Q3W, or sintilimab 200 mg Q3W) for patients without immunotherapy contraindications. Treatment continues up to 8 cycles with tumor assessment every 3 cycles; surgery timing at investigator's discretion.
Adjuvant therapy: For the neoadjuvant cohort, adjuvant therapy (4-5 cycles starting 4-6 weeks post-surgery) may be administered at the investigator's discretion. Total perioperative treatment duration should not exceed 8 cycles. Conversion cohort adjuvant therapy is at the investigator's discretion.
Endpoints: Primary endpoint is pathological complete response (pCR, ypT0N0). Secondary endpoints include MPR, R0 resection rate, down-staging rate, NCCN TRG 0/1, RFS, OS, treatment completion rate, and safety (CTCAE v5.0). Conversion cohort additionally evaluates ORR (RECIST v1.1, with iRECIST for pseudoprogression), PFS, and surgical conversion rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Cohort: Zanidatamab + Chemotherapy | Experimental | Drug: Zanidatamab, Drug: Oxaliplatin, Drug: Capecitabine, Drug: S-1Patients with previously untreated stage III locally advanced gastric/gastroesophageal junction adenocarcinoma (cT3-4aN+M0, or cT4bNany M0 not amenable to R0 resection per MDT assessment) receive 3 cycles of zanidatamab (30 mg/kg Q3W) plus oxaliplatin-based chemotherapy (SOX: oxaliplatin 130 mg/m2 IV D1 + S-1 40 mg/m2 PO BID D1-14, Q3W; or CAPOX: oxaliplatin 130 mg/m2 IV D1 + capecitabine 1000 mg/m2 PO BID D1-14, Q3W), followed by D2 radical gastrectomy 4-6 weeks after treatment. Simon's two-stage design: n=46, H0 pCR <= 9.6%, H1 pCR >= 25%, one-sided alpha=0.05, power=80%. |
| Conversion Cohort: Zanidatamab + Chemotherapy +/- PD-1 Inhibitor | Experimental | Drug: Zanidatamab, Drug: Oxaliplatin, Drug: Capecitabine, Drug: S-1, Drug: TislelizumabPatients with oligometastatic disease (M1, <=2 organs, <=5 total lesions, including liver metastases C-GCLM type I/II, retroperitoneal lymph node metastases, or other single-organ metastases) deemed potentially resectable by MDT receive zanidatamab (30 mg/kg Q3W) plus oxaliplatin-based chemotherapy, plus tislelizumab (200 mg Q3W) or sintilimab (200 mg Q3W) if no immunotherapy contraindication. Up to 8 cycles, tumor assessment every 3 cycles. Exploratory cohort; no sample size calculation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Willing and able to provide written informed consent (ICF).
- Histologically and radiologically (CT/MRI) confirmed gastric or gastroesophageal junction adenocarcinoma.
- HER2-positive by IHC (3+; or 2+ with FISH testing). No time window restriction on FISH.
- Age 18-75 years, male or female.
- ECOG performance status 0-1; no contraindication to surgery.
Key exclusion criteria (16 listed)
- Synchronous or metachronous malignancies of other organs, or recurrent disease.
- Prior systemic therapy for gastric cancer (neoadjuvant cohort).
- History of malignancy within 5 years before screening, except those with > 90% 5-year overall survival.
- Significant cardiopulmonary dysfunction.
- Major surgery within 4 weeks before study treatment initiation, or anticipated major surgery during study period (excluding diagnostic procedures).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZanidatamabAlso: ZIIHERAZanidatamab 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 | Conversion Cohort: Zanidatamab + Chemotherapy +/- PD-1 Inhibitor, Neoadjuvant Cohort: Zanidatamab + Chemotherapy |
| OxaliplatinAlso: EloxatinOxaliplatin 130 mg/m2 IV infusion over > 2 hours, D1 of each 21-day cycle. Administered after zanidatamab. Manufacturer not restricted. | Drug | Conversion Cohort: Zanidatamab + Chemotherapy +/- PD-1 Inhibitor, Neoadjuvant Cohort: Zanidatamab + Chemotherapy |
| CapecitabineAlso: XelodaCapecitabine 1000 mg/m2 PO BID, D1-14 of each 21-day cycle. Alternative to S-1 as part of CAPOX backbone. | Drug | Conversion Cohort: Zanidatamab + Chemotherapy +/- PD-1 Inhibitor, Neoadjuvant Cohort: Zanidatamab + Chemotherapy |
| S-1Also: TeysunoS-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 | Conversion Cohort: Zanidatamab + Chemotherapy +/- PD-1 Inhibitor, Neoadjuvant Cohort: Zanidatamab + Chemotherapy |
| TislelizumabAlso: BGB-A317Tislelizumab 200 mg Q3W IV. Alternatively, sintilimab 200 mg Q3W may be used at investigator's discretion. Conversion cohort only, for patients without immunotherapy contraindication. | Drug | Conversion Cohort: Zanidatamab + Chemotherapy +/- PD-1 Inhibitor |
Primary outcome
Pathological Complete Response (pCR)
Time frame: At the time of surgery, approximately 4-6 weeks after completion of 3 cycles of neoadjuvant treatment (each cycle is 21 days)
pCR is defined as the absence of residual tumor cells in the primary tumor and all resected lymph nodes (ypT0N0) after neoadjuvant treatment, assessed by histopathological evaluation of surgical specimens.
11 secondary outcomes
Major Pathological Response (MPR)
Time frame: At the time of surgery, approximately 4-6 weeks after completion of neoadjuvant treatment
R0 Resection Rate
Time frame: At the time of surgery, approximately 4-6 weeks after completion of neoadjuvant treatment
Down-Staging Rate
Time frame: At the time of surgery, approximately 4-6 weeks after completion of neoadjuvant treatment
Tumor Regression Grade 0/1 Rate (NCCN TRG)
Time frame: At the time of surgery, approximately 4-6 weeks after completion of neoadjuvant treatment
Recurrence-Free Survival (RFS)
Time frame: From date of complete response after treatment until date of recurrence or death, assessed up to 60 months
Overall Survival (OS)
Time frame: From date of enrollment until date of death from any cause, assessed up to 36 months
Objective Response Rate (ORR) - Conversion Cohort
Time frame: Every 3 cycles during conversion treatment (up to 8 cycles, each cycle is 21 days), assessed per RECIST v1.1
Progression-Free Survival (PFS) - Conversion Cohort
Time frame: From date of enrollment until date of disease progression or death, assessed up to 36 months
Neoadjuvant Treatment Completion Rate
Time frame: At the end of neoadjuvant treatment period, approximately 9 weeks (3 cycles of 21 days each)
Surgical Conversion Rate - Conversion Cohort
Time frame: During conversion treatment period, up to 8 cycles (each cycle is 21 days)
Incidence of Treatment-Emergent Adverse Events
Time frame: From first dose through 30 days after last dose of study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianjun Yang, Prof. principal investigator
Department of Digestive Surgery, Xijing Hospital, Air Force Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zanidatamab, Oxaliplatin and Capecitabine in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by Zhifeng Zhao, PhD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianjun Yang, Prof. (+86-029-84775507, yangjj@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) (time frame: At the time of surgery, approximately 4-6 weeks after completion of 3 cycles of neoadjuvant treatment (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.