TACE Combined With Thermal Ablation and ADC, PD-1, and Chemotherapy as First-line Treatment for HER2-highly-expressing Gastric Cancer With Liver Metastases: A Multicenter, Single-arm Prospective Clinical Study.

NCT07602140 | Not Yet Recruiting Phase 2

• 1 other identifier: NO.2026-1015-1
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a multicenter, single-arm prospective clinical trial designed to evaluate the efficacy of TACE combined with thermal ablation, antibody-drug conjugates, immune checkpoint inhibitors, and first-line chemotherapy for the treatment of HER2 - highly expressing gastric cancer with liver metastases.

Conditions

Gastric Cancer With Liver Metastases

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  The proportion of subjects who achieve complete response (CR) and partial response (PR) among the total subjects.

  Approximately 1 month after imaging examination

Secondary Outcomes (5)

• Progression-Free Survival（PFS）

  Approximately 1 day after disease progression or death from any cause in cancer patients.

• Disease Control Rate（DCR）

  Approximately 1 month after imaging examinatio

• Overall Survival (OS)

  Approximately 2 years after last participant enrollment

• Adverse Event (AE)

  Approximately 2 month after any treatment

• R0 resection rate

  According to the postoperative pathological results, it is generally 2 weeks after surgery

Study Arms (1)

Interventional therapy + Chemotherapy + Targeted Therapy + Immunotherapy

EXPERIMENTAL

Other: TACE combined with thermal ablation; Drug: Targeted Therapy; Drug: Immunotherapy; Drug: Chemotherapy

Interventions

TACE combined with thermal ablation OTHER

The decision to perform transarterial chemoembolization (TACE) and/or thermal ablation is based on the blood supply, size, and number of liver metastases as determined by imaging examinations. Interventional therapy is repeated every two cycles, and TACE and/or thermal ablation therapy are selected based on the blood supply, location, size and number of liver metastases.

Interventional therapy + Chemotherapy + Targeted Therapy + Immunotherapy

Targeted Therapy DRUG

Disitamab Vedotin For Injection: 2.5 mg/kg, day 1, IV drip , Q3W.

Interventional therapy + Chemotherapy + Targeted Therapy + Immunotherapy

Immunotherapy DRUG

Sintilimab : 200mg , d1 , ivdrip , q3w

Interventional therapy + Chemotherapy + Targeted Therapy + Immunotherapy

Chemotherapy DRUG

S-1 : 40-60 mg/dose, orally, twice daily (bid), daily (days 1-14) , every 3 weeks (q3w).

Interventional therapy + Chemotherapy + Targeted Therapy + Immunotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants voluntarily joined this study, signed informed consent forms, demonstrated good compliance, and cooperated with follow-up.
• Male or female, aged 18 or older and 75 or younger;
• ECOG score is 0-1;
• Expected survival time ≥ 3 months;
• Imaging examinations suggest gastric cancer with liver metastasis;
• Histopathologically confirmed gastric adenocarcinoma and liver metastatic adenocarcinoma;
• Enhanced CT scans were used to observe the staining of liver metastases; tumors with good blood supply were included in this study.
• Immunohistochemical results of gastric adenocarcinoma and/or liver metastatic adenocarcinoma confirmed high expression of HER2 (defined as: IHC 2+ or 3+);
• No prior history of antibody-drug conjugate ( ADC ) therapy ; Note: Patients who have relapsed more than 6 months after receiving neoadjuvant (radiotherapy) chemotherapy + radical surgery, or who have relapsed more than 6 months after completing adjuvant (radiotherapy) chemotherapy or radical concurrent chemoradiotherapy;
• Within 28 days prior to the first administration of the study drug, the target lesion had not received local treatment (including transarterial chemoembolization/TACE, hepatic artery infusion chemotherapy/TAC, radiotherapy, radiation embolization or ablation, etc.);
• There must be at least one liver metastasis meeting the following criteria:
• At least one patient is eligible for TACE and/or thermal ablation treatment; 12. In addition to the ablated lesion, there is at least one measurable lesion in the liver or outside the liver (according to RECIST 1.1 criteria, the long axis of the tumor lesion on CT scan is ≥10 mm, and the short axis of the lymph node lesion on CT scan is ≥10 mm) (for assessing the remote effect).
• Damage caused by other treatments received by the subject has recovered, including those received other cytotoxic drugs, radiotherapy or surgery for ≥4 weeks, and the wounds have completely healed ; 1.4 . Subjects should not have previously received anti-PD-1, PD-L1, CTLA-4, or CAR-T immunotherapy ; 1.5 . Asymptomatic brain metastases or control of brain metastases after radiotherapy ; 1.6 . Major organ functions are normal, and subjects must meet the following laboratory indicators:
• )In the absence of granulocyte colony-stimulating factor use in the past 14 days, the absolute neutrophil count (ANC) is ≥1.5 x 10⁹ /L .
• )10⁹ /L without blood transfusion in the past 14 days ; 3)Hemoglobin \>9 g/dL in the absence of blood transfusion or erythropoietin use within the past 14 days ; 4)There is no active bleeding, such as hematemesis, melena, gingival bleeding, epistaxis, or hemorrhoidal bleeding, and the fecal occult blood test is ≤ +.

You may not qualify if:

• diagnosed with other malignant tumors within 5 years prior to the first dose and who are not cured (excluding radically resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been radically removed);
• Currently participating in interventional clinical research treatment, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first dose;
• Previous treatment with the following: antibody-drug conjugates, anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or co-inhibit T cell receptors (e.g. CTLA-4, OX-40, CD137);
• Within 28 days prior to the first administration of the study drug, the target lesion had received local treatment (including transarterial chemoembolization/TACE, hepatic artery infusion chemotherapy/TAC, radiotherapy, radioembolization or ablation, etc.);
• The patient had received systemic treatment with traditional Chinese medicine or immunomodulatory drugs with antitumor indications within 2 weeks prior to the first dose ;
• Subjects with any active autoimmune disease or a history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or whose childhood asthma was completely remitted and requires no intervention in adulthood are eligible to be included; subjects with asthma requiring medical intervention with bronchodilators are not eligible to be included).
• Subjects are currently using immunosuppressants, or systemic or absorbable topical corticosteroids, to achieve immunosuppression (dose \>10 mg/ day prednisone or other equivalent corticosteroids), and have continued to use them within 2 weeks prior to enrollment; Note: Physiological doses of glucocorticoids (≤10 mg/day prednisone or equivalent drugs) are permitted.
• Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
• known hypersensitivity to the study drugs vedicetumab , sintilimab, and tegafur ;
• Active gastrointestinal bleeding or high risk of bleeding within 2 weeks prior to screening; or gastrointestinal perforation/fistula within 6 months prior to screening; intestinal obstruction, within 30 days after major surgery, uncontrolled hypertension, NYHA class III-IV heart failure, or severe hepatic or renal failure (class 4).
• Prior to starting treatment, the individual has not fully recovered from any toxicity and/or complications caused by any intervention (i.e., ≤ grade 1 or at baseline, excluding fatigue or hair loss).
• Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive );
• Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number greater than the upper limit of normal value in the laboratory of the research center);
• Note : Hepatitis B subjects who meet the following criteria may also be enrolled :
• before the first dose , the subject should receive anti-HBV therapy throughout the study chemotherapy treatment to avoid viral reactivation.

Sponsors & Collaborators

• Shandong Provincial Hospital: lead

Related Publications (4)

• Xu J, Jiang H, Pan Y, Gu K, Cang S, Han L, Shu Y, Li J, Zhao J, Pan H, Luo S, Qin Y, Guo Q, Bai Y, Ling Y, Yang J, Yan Z, Yang L, Tang Y, He Y, Zhang L, Liang X, Niu Z, Zhang J, Mao Y, Guo Y, Peng B, Li Z, Liu Y, Wang Y, Zhou H; ORIENT-16 Investigators. Sintilimab Plus Chemotherapy for Unresectable Gastric or Gastroesophageal Junction Cancer: The ORIENT-16 Randomized Clinical Trial. JAMA. 2023 Dec 5;330(21):2064-2074. doi: 10.1001/jama.2023.19918.

  PMID: 38051328 RESULT

• Peng Z, Liu T, Wei J, Wang A, He Y, Yang L, Zhang X, Fan N, Luo S, Li Z, Gu K, Lu J, Xu J, Fan Q, Xu R, Zhang L, Li E, Sun Y, Yu G, Bai C, Liu Y, Zeng J, Ying J, Liang X, Xu N, Gao C, Shu Y, Ma D, Dai G, Li S, Deng T, Cui Y, Fang J, Ba Y, Shen L. Efficacy and safety of a novel anti-HER2 therapeutic antibody RC48 in patients with HER2-overexpressing, locally advanced or metastatic gastric or gastroesophageal junction cancer: a single-arm phase II study. Cancer Commun (Lond). 2021 Nov;41(11):1173-1182. doi: 10.1002/cac2.12214. Epub 2021 Oct 19.

  PMID: 34665942 RESULT

• Wang X, Fan B, Liu S. Comprehensive treatment focusing on transarterial chemoembolization for postoperative liver metastasis in gastric cancer patients. Am J Transl Res. 2024 Dec 15;16(12):7330-7342. doi: 10.62347/KWBT3893. eCollection 2024.

  PMID: 39822559 RESULT

• Vogl TJ, Gruber-Rouh T, Eichler K, Nour-Eldin NE, Trojan J, Zangos S, Naguib NN. Repetitive transarterial chemoembolization (TACE) of liver metastases from gastric cancer: local control and survival results. Eur J Radiol. 2013 Feb;82(2):258-63. doi: 10.1016/j.ejrad.2012.10.006. Epub 2012 Nov 3.

  PMID: 23127803 RESULT

MeSH Terms

Interventions

Immunotherapy; Drug Therapy

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Central Study Contacts

Dan SHA

CONTACT

+86 13573175130; shadan@sdfmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: May 22, 2026

Record last verified: 2026-05