Disitamab Vedotin Combined With Tislelizumab and Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Cancer With HER2 Overexpression

NCT06560528 | Recruiting Phase 2

• 1 other identifier: E20241606
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The efficacy and safety of combination with Disitamab Vedotin and with Tislelizumab and Capecitabine for perioperative treatment of locally advanced gastric cancer with HER2 overexpression.

Conditions

Gastric Cancer; Gastroesophageal Junction Adenocarcinoma

Keywords

RC48-ADC; HER2

Outcome Measures

Primary Outcomes (1)

• Pathologic complete remission rate (PCR)

  Pathological complete response (pCR) rate is defined as the proportion of participants whose tumor in the stomach and lymph node completely disappeared, as determined by a pathologist.

  up to 1 years

Secondary Outcomes (5)

• Objective response rate(ORR)

  up to 3 years

• Major pathological response rate (MPR)

  up to 1 year

• 1-3-years event-free survival rate of 3year (EFS)

  up to 3 years

• 1-3 years overall survival (OS) rate

  up to 3 years

• Adverse Events（AEs）

  up to 3 years

Study Arms (1)

combination with Disitamab Vedotin and with Tislelizumab and Capecitabine

EXPERIMENTAL

Subjects will receive Disitamab Vedotin combined with Tislelizumab and Capecitabine for 3 cycles (Q3W) in the neoadjuvant phase and 5 cycles (Q3W) of treatment in the adjuvant phase. Disitamab Vedotin：2.5 mg/kg，Q3W； Tislelizumab：200 mg，Q3W； Capecitabine：1000 mg /m2, PO, bid d1-14, Q3W.

Drug: combination with Disitamab Vedotin and with Tislelizumab and Capecitabine

Interventions

combination with Disitamab Vedotin and with Tislelizumab and Capecitabine DRUG

Subjects will receive Disitamab Vedotin combined with Tislelizumab and Capecitabine for 3 cycles (Q3W) in the neoadjuvant phase and 5 cycles (Q3W) of treatment in the adjuvant phase. 1. Disitamab Vedotin：2.5 mg/kg，Q3W； 2. Tislelizumab：200 mg，Q3W； 3. Capecitabine：1000 mg /m2, PO, bid d1-14, Q3W.

combination with Disitamab Vedotin and with Tislelizumab and Capecitabine

Eligibility Criteria

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

You may qualify if:

• \) Volunteer to take part in the study ;
• \) Age 18\~75 (including 75), male or female;
• \) Gastric cancer or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology;
• \) Clinical stage Ⅱ, Ⅲ (cT2-4a ,N+ or -, M0, AJCC 8th);
• \) Have not received systematic treatment;
• \) The HER2 immunohistochemistry (IHC) test result is IHC 3+or 2+, and the previous test results of the subject (confirmed by the investigator) are acceptable;
• \) At least one assessable lesion (RECIST 1.1 );
• \) Expected survival time ≥ 6 months;
• \) ECOG 0-1;
• \) Major organs are functioning normally；

You may not qualify if:

• \) Have a history of malignant tumors other than gastric cancer, except for the following two cases:
• The patient has received possible curative treatment and there is no evidence of the disease within 5 years;
• The resected skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ and other carcinoma in situ were successfully received;
• \) Suffering from diseases that affect the absorption, distribution, metabolism or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorder, etc.);
• \) Have received allogeneic stem cells or solid organ transplantation in the past;
• \) Patients who have received other anti-tumor systemic therapy in the past (including traditional Chinese medicine with anti-tumor indications), and have been less than 4 weeks from the completion of treatment to the administration of this study, or the adverse events caused by previous treatment have not recovered to ≤ CTCAE level 1 (except hair loss and pigmentation);
• \) Previous or current congenital or acquired immunodeficiency disease;
• \) Active or previously recorded autoimmune diseases or inflammatory diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, hypophysitis, hyperthyroidism or hypothyroidism, asthma requiring bronchodilators, etc.), vitiligo or asthma that has completely alleviated in childhood, Those who do not need any intervention after adulthood can be included;
• \) Systemic immunosuppressive drugs were used within 2 weeks before enrollment, or were expected to be required during the study, except for the following:
• Corticosteroids for intranasal, inhalation, external or local injection (such as intra-articular injection);
• The dose of prednisone or other equivalent systemic corticosteroids does not exceed 10 mg/day;
• Preventive use of corticosteroids for hypersensitivity;
• \) Allergic to the study drug;
• \) Thrombosis or thromboembolism events occurred in the past 6 months, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc;
• \) Patients at risk for severe bleeding；

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (2)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Xuewei Ding

Tianjin, Tianjin Municipality, 300308, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

disitamab vedotin; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Han Liang, Ph.D

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

• Xuewei Ding, Ph.D

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuewei Ding, Ph.D

CONTACT

18622220158; xding@tmu.edu.cn

Han Liang, Ph.D

CONTACT

Study Design

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

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)