Combination treatment for advanced HER2-positive gastric cancer

A Phase II, Open-Label, Multicenter Trial Comparing 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 (RCTS2)

This study is testing a new combination of treatments for people with advanced HER2-positive gastric cancer to see if it works better than the standard chemotherapy options.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Qilu Hospital of Shandong University (Academic / other)
• Drugs / interventions: chemotherapy, Disitamab, Sintilimab, Trastuzumab
• Locations: 20 sites (Zhengzhou, Henan and 19 other locations)
• Trial ID: NCT06730373 on ClinicalTrials.gov

What this trial studies

This Phase II clinical trial evaluates the effectiveness of Disitamab Vedotin combined with Sintilimab and S-1 compared to Trastuzumab plus chemotherapy with or without Sintilimab for patients with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma. The study is randomized, multicenter, and open-label, aiming to determine the best first-line treatment approach for this patient population. Participants will be monitored for measurable lesions and overall response to the treatment regimen.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with pathologically confirmed HER2-positive locally advanced or metastatic gastric cancer.

Not a fit: Patients with serious allergies to trial drugs or those with uncontrolled cardiovascular or cerebrovascular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective first-line therapy option for patients with advanced HER2-positive gastric cancer.

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

Eligibility criteria

Inclusion Criteria:

1. Aged18-75 years, gender is not limited;
2. Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis;
3. HER2-Positive (IHC3+or IHC2+/FISH+) ;
4. Has at least 1 measurable lesion as determined by RECIST 1.1;
5. There is no systematic treatment in the past, or the patient has received neoadjuvant/adjuvant chemotherapy, but the disease progresses or relapses more than 6 months after the end of treatment;
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
7. Adequate organ function;
8. The life expectancy is at least 3 months;

Exclusion Criteria:

1. Allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug;
2. Cardiovascular and cerebrovascular events that are not well controlled;
3. Has received systematic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for ascites control) before the first administration within 2 weeks.
4. Have a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control (including but not limited to diabetes, hypertension, etc.);
5. Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases;
6. Severe chronic or active infection requires systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection.Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment;
7. Brain metastasis or leptomeningeal metastasis;
8. Clinically significant pleural effusion, pericardial effusion or ascites should be drained for many times within 2 weeks before the first administration of the trial drug;
9. Has a second clinically detectable primary malignant tumor at the time of recruitment, or there were other malignant tumors in the past 5 years (except for fully treated skin basal cell carcinoma or cervical carcinoma in situ);
10. Any major surgery was performed ≤ 28 days before the first trial drug administration;
11. History of allogeneic stem cell transplantation or organ transplantation;

Where this trial is running

Zhengzhou, Henan and 19 other locations

• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
• Binzhou Medical University Hospital — Binzhou, Shandong, China (Not_yet_recruiting)
• Shengli Oilfield Central Hospital — Dongying, Shandong, China (Recruiting)
• Shandong Provincial Hospital Affiliated to Shandong First Medical University — Jinan, Shandong, China (Recruiting)
• Shandong Provincial Third Hospital — Jinan, Shandong, China (Recruiting)
• Shandong Univerisity Qilu Hospital — Jinan, Shandong, China (Recruiting)
• Jinan Third People's Hospital — Jinan, Shandong, China (Recruiting)
• Affiliated Hospital of Jining Medical College — Jining, Shandong, China (Recruiting)
• Liaocheng People's Hospital — Liaocheng, Shandong, China (Recruiting)
• Linyi Cancer Hospital — Linyi, Shandong, China (Recruiting)
• Qilu Hospital of Shandong University(Qingdao) — Qingdao, Shandong, China (Recruiting)
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Not_yet_recruiting)
• Taian City Central Hospital — Taian, Shandong, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Shandong First Medical University — Taian, Shandong, China (Recruiting)
• Tengzhou Central People's Hospital — Tengzhou, Shandong, China (Recruiting)
• Weifang Hospital of Traditional Chinese Medicine — Weifang, Shandong, China (Not_yet_recruiting)
• Yantai Yuhuangding Hospital — Yantai, Shandong, China (Recruiting)
• Yantaishan Hospital — Yantai, Shandong, China (Recruiting)
• Zibo Central Hospital — Zibo, Shandong, China (Recruiting)
• Zibo First People's Hospital — Zibo, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Lian Liu, MD

Conditions HER2-positive Gastric Cancer; Metastatic Gastric Cancer; Unresectable Gastric Carcinoma