Her2 Positive Gastric Cancer

13

Review clinical trials related to Her2 Positive Gastric Cancer. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer

This is a Phase Ⅲ, randomized, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm.

Participants needed: 840
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: AstraZenecaUpdated: Jun 16, 2026Locations: 293
Eligibility criteria

HER2 positive for gastric cancer on a tumor biopsy. [+8]

Lack of physiological integrity of the upper gastrointestinal tract. [+19]

Status: Recruiting

A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer

This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).

Participants needed: 550
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Shanghai Henlius BiotechUpdated: Feb 27, 2026Locations: 208
Eligibility criteria

Male/female who are at least 18 years of age on the day of signing the informed... [+6]

Patients with other malignant tumors within 2 years before the randomization. [+6]

Status: Not yet recruiting

A Study of KN026-based Combination Therapy in HER2-positive Gastric Cancer

This study is designed to compare the efficacy and safety of KN026 combined chemotherapy with or without Enlonstobart versus Trastuzumab combined chemotherapy with or without Pembrolizumab as first-line treatment in HER2-positive unresectable locally advanced or metastatic gastric cancer.

Participants needed: 490
Trial details
Phase: Phase 2, Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Shanghai JMT-Bio Inc.Updated: Jan 12, 2026
Eligibility criteria

Histologically or cytologically confirmed diagnosis of gastric cancer. [+8]

Has received anti-tumor treatment such as systemic chemotherapy or other trial i... [+21]

Status: Recruiting

Fruquintinib Combined With Trastuzumab and XELOX as First-line Treatment in Patients With HER2-positive Advanced Gastric Cancer

This study was designed to evaluate the safety and efficacy of fruquintinib plus trastuzumab, and XELOX as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Participants needed: 45
Trial details
Phase: Phase 1, Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Henan Cancer HospitalUpdated: Jan 12, 2026Locations: 1
Eligibility criteria

Have fully understood the study and voluntarily signed the informed consent; [+16]

Failure to comply with the study protocol or study procedure; [+25]

Status: Recruiting

HER-2 B Cell Peptide Vaccine

This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with metastatic solid tumors. Vaccines made from antibodies and peptides combined with tumor cells may help the body build an effective immune response to kill tumor cells.

Participants needed: 42
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Pravin T.P KaumayaUpdated: Aug 24, 2025Locations: 1
Eligibility criteria

For the extension cohort to be conducted at the IUSCCC (N=12), patients with his... [+20]

Patients with tumors that are negative for HER-2 expression based on IHC of 0 AN... [+9]

Status: Recruiting

Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China

Trastuzumab deruxtecan's (T-DXd's) efficacy and safety has been confirmed in traditional clinical trials, there is a lack of real-world evidence, especially among Chinese patients. The objective of this study is to evaluate real-world effectiveness and safety profile of T-DXd by collecting real-world data treating in patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.

Participants needed: 260
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Daiichi SankyoUpdated: Jul 8, 2025Locations: 36
Eligibility criteria

Participants with pathologically diagnosed locally advanced unresectable or meta... [+4]

Pregnancy or breastfeeding. [+3]

Status: Not yet recruiting

JSKN003 Combined Treatment of HER2-positive Gastric Cancer

This study is designed to evaluate the safety and efficacy of JSKN003 combination therapy as first-line treatment in HER2-positive unresectable locally advanced or metastatic gastric cancer or resectable gastric cancer.

Participants needed: 153
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Shanghai JMT-Bio Inc.Updated: May 31, 2025
Eligibility criteria

Age≥18 years old. [+9]

Has received anti-tumor treatment such as systemic chemotherapy or other trial i... [+22]

Status: Recruiting

First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)

This is a Phase II, randomized, multicenter, open-label clinical trial designed to compare Disitamab Vedotin plus Sintilimab and S-1 with Trastuzumab plus chemotherapy ± Sintilimab for first-line treatment of HER2-Positive advanced gastric or gastroesophageal junction adenocarcinoma.

Participants needed: 110
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Qilu Hospital of Shandong UniversityUpdated: Dec 31, 2024Locations: 20
Eligibility criteria

Aged18-75 years, gender is not limited; [+7]

Allergy to any trial drug and its excipients, or serious allergy history, or con... [+10]

Status: Recruiting

Perioperative Chemotherapy Plus Trastuzumab Plus Toripalimab in HER2 Positive Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma

This study is a prospective, single arm, multi-center phase II clinical trial designed to evaluate the efficacy and safety of perioperative chemotherapy with FLOT regimen and trastuzumab in combination with toripalimab in participants with resectable HER2 positive locally advanced gastric or esophagogastric junction adenocarcinoma.

Participants needed: 30
Trial details
Phase: Phase 2Age: 18-80Biological sex: AllType: InterventionalSponsor: Yu jirenUpdated: Sep 19, 2024Locations: 8
Eligibility criteria

Voluntary participation in the clinical study; fully understands and is informed... [+25]

Prior systemic therapy for treatment of gastric cancer (surgery, chemotherapy, r... [+15]

Status: Recruiting

Disitamab Vedotin Plus Trastuzumab in Patients With HER2 Positive GC/GEJ Patiens

This trial is a single center, single arm, open label clinical study aimed at evaluating the efficacy and safety of the combination therapy of Disitamab Vedotin and trastuzumab in the treatment of advanced HER-2 positive gastric/gastroesophageal junction tumors

Participants needed: 35
Trial details
Phase: Phase 1, Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Zhejiang Cancer HospitalUpdated: Aug 27, 2024Locations: 1
Eligibility criteria

Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets ≥ 90 × 109/L, or [+3]

Known to be allergic to the received therapeutic drugs or excipients; [+16]

Status: Not yet recruiting

RC48 Plus AK104 as First-line Treatment for HER2-overexpressing Advanced Gastric Cancer

A single-arm, single-center phase II trial study to assess the efficacy and safety of disitamab vedotin plus cadonilimab as first-line therapy for HER2-overexpressing advanced stomach carcinoma

Participants needed: 20
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: The First Affiliated Hospital of Zhengzhou UniversityUpdated: Jul 9, 2024Locations: 1
Eligibility criteria

Age: more than 18 years, gender is not limited; [+15]

Allergy to any trial drug and its excipients, or serious allergy history, or con... [+22]

Status: Recruiting

Adjuvant TRastuzumab Deruxtecan for HER2-positive Gastroesophageal Cancer With Persistence of miNImal Residual Disease

TRINITY is designed as a multicentre, randomized, open-label, interventional phase II study aimed at investigating the activity, efficacy and safety of trastuzumab-deruxtecan (T-DXd) plus capecitabine/5-fluorouracil as a post-operative treatment in localized/locally advanced gastric or gastroesophageal junction cancer (GC/GEJC)/esophageal adenocarcinoma patients with HER2 overexpression/amplification and positive post-operative ctDNA after pre-operative 5-fluorouracil plus leucovorin, oxaliplatin, and docetaxel (FLOT) regimen followed by radical surgery.

Participants needed: 46
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Gruppo Oncologico del Nord-OvestUpdated: Jun 13, 2024Locations: 1
Eligibility criteria

Written informed consent and any locally required authorization (such as the Eur... [+21]

Involvement in the planning and/or conduct of the study (applies to both Investi... [+25]

Status: Not yet recruiting

Adjuvant Treatment With Serplulimab,Trastuzumab and SOX in the HER-2 Positive GC/GEJC

This is a prospective, single arm, multicenter phase II study to assess the effectiveness of Serplulimab,Trastuzumab and SOX in the adjuvant treatment of HER-2 Positive Gastric/Gastroesophageal Junction Carcinoma (GC/GEJC)

Participants needed: 42
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: The First Affiliated Hospital of Zhengzhou UniversityUpdated: Jun 3, 2024
Eligibility criteria

Histologically confirmed gastric adenocarcinoma/esophagogastric junction adenoca... [+8]

A history of any other malignancy in the past 5 years (except carcinoma in situ... [+15]