Combination treatment for advanced gastric cancer with HER2 overexpression

Clinical Study on the Efficacy and Safety of Disitamab Vedotin Combined With Tislelizumab and Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Cancer With HER2 Overexpression

This study is testing a new combination treatment for patients with advanced gastric cancer that has high levels of HER2 to see if it can improve their outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: prednisone, Disitamab, Tislelizumab
• Locations: 2 sites (Tianjin, Tianjin Municipality and 1 other locations)
• Trial ID: NCT06560528 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of a combination treatment involving Disitamab Vedotin, Tislelizumab, and Capecitabine for patients with locally advanced gastric cancer or gastroesophageal junction adenocarcinoma that overexpresses HER2. A total of 40 patients who have not received prior anti-tumor therapy will undergo perioperative treatment, which includes both neoadjuvant and adjuvant phases. The neoadjuvant phase consists of 3 cycles of treatment, followed by 5 cycles in the adjuvant phase, with the aim of improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with HER2 overexpressing locally advanced gastric cancer or gastroesophageal junction adenocarcinoma who have not received prior systemic therapy.

Not a fit: Patients with a history of other malignancies or those who have received previous anti-tumor systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with advanced gastric cancer.

How similar studies have performed: Other studies have shown promising results with similar combination therapies targeting HER2 in gastric cancer, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

* 1\) Have a history of malignant tumors other than gastric cancer, except for the following two cases:

  1. The patient has received possible curative treatment and there is no evidence of the disease within 5 years;
  2. 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;
* 2\) 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.);
* 3\) Have received allogeneic stem cells or solid organ transplantation in the past;
* 4\) 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);
* 5\) Previous or current congenital or acquired immunodeficiency disease;
* 6\) 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;
* 7\) Systemic immunosuppressive drugs were used within 2 weeks before enrollment, or were expected to be required during the study, except for the following:

  1. Corticosteroids for intranasal, inhalation, external or local injection (such as intra-articular injection);
  2. The dose of prednisone or other equivalent systemic corticosteroids does not exceed 10 mg/day;
  3. Preventive use of corticosteroids for hypersensitivity;
* 8\) Allergic to the study drug;
* 9\) Thrombosis or thromboembolism events occurred in the past 6 months, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc;
* 10\) Patients at risk for severe bleeding；
* 11\) Cardiovascular diseases with significant clinical significance;
* 12\) Other significant clinical and laboratory abnormalities, which the researchers think affect the safety evaluation;
* 13\) Serious infection in active period or poorly controlled clinically;
* 14\) Not recovered from the operation;
* 15\) Pregnant or lactating women, and women or men with fertility who are unwilling or unable to take effective contraceptive measures;
* 16\) Other situations that the investigator thinks are not suitable for inclusion.

Where this trial is running

Tianjin, Tianjin Municipality and 1 other locations

• Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
• Xuewei Ding — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Principal investigator: Han Liang, Ph.D — Tianjin Medical University Cancer Institute and Hospital
• Study coordinator: Xuewei Ding, Ph.D

Conditions Gastric Cancer; Gastroesophageal Junction Adenocarcinoma; RC48-ADC; HER2