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

Trial Title: First-line Treatment With RC48 Plus Tislelizumab and S-1(RCTS) in Advanced Gastric Cancer

NCT ID: NCT05586061

Condition: HER2-positive Gastric Cancer

Conditions: Official terms:
Stomach Neoplasms
Tislelizumab
Disitamab vedotin

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Disitamab vedotin
Description: Disitamab Vedotin: 2.5mg/kg, d1, ivdrip, (every 3 weeks) Q3W
Arm group label: RC48 Plus Tislelizumab and S-1(RCTS)

Other name: RC48

Intervention type: Drug
Intervention name: Tislelizumab
Description: Tislelizumab: 200mg, d1, ivdrip, (every 3 weeks) Q3W
Arm group label: RC48 Plus Tislelizumab and S-1(RCTS)

Other name: BGB-A317

Intervention type: Drug
Intervention name: S1
Description: S-1: 40-60mg (according to patients' body surface area), po, bid, d1-14, discontinued for 7 days.
Arm group label: RC48 Plus Tislelizumab and S-1(RCTS)

Summary: This is a prospective, single arm, multicenter phase II study aimed at evaluating the efficacy and safety of Disitamab Vedotin in Combination With Tirelizumab and S-1 as first-line treatment for patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma.

Criteria for 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 was detected as 2+or 3+ by immunohistochemistry（IHC） ; 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: 1. Bone marrow function: i. Hemoglobin count (HGB)≥80g/L; ii. Neutrophil count (NE)≥1.5×109/L; iii. White blood cell count (WBC)≥3.5×109/L; iv. Platelet count (PLT)≥100×109/L； 2. Liver function: i. Serum total bilirubin (TBIL)≤1.5×ULN; ii. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP)≤3×ULN, patients with liver metastasis≤5×ULN; 3. Kidney function: Blood creatinine (Cr) ≤1.5×ULN or Cockcroft Gault formula ≥ 60 mL/min; 4. Cardiac function: New York Heart Association (NYHA) classification140 mmHg or diastolic blood pressure>90 mmHg after single drug treatment; 8. Patients with history of arterial thrombosis or deep vein thrombosis within 6 months before recruitment, or with evidence of bleeding tendency or medical history within 2 months before recruitment, regardless of the severity; 9. Stroke event or transient ischemic attack occurred within 12 months before recruitment; 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; 12. Duodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases at present; or other conditions that may cause gastrointestinal bleeding or perforation judged by the researchers; or history of intestinal perforation or fistula, but has not recovered after surgical treatment; 13. Live vaccine was inoculated within 4 weeks (inclusive) before the first administration of the trial drug, not including seasonal influenza vaccines but intranasal vaccine. 14. Has other factors that may lead to the forced termination of this trial according to the judgment of the investigator, such as other serious diseases (including psychological and mental diseases) requiring combined treatment, serious laboratory examination abnormalities, and family or social factors, which may affect the safety of the subject, or the collection of data and samples; 15. Participating in other therapeutic clinical studies or using research instruments within 4 weeks before the first administration; 16. Others conditions do not meet the inclusion according to the judgment of the investigator.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Central Hospital Affiliated to Shandong First Medical University

Address:
City: Jinan
Zip: 250012
Country: China

Contact:
Last name: Meili Sun, Doctor
Email: smli1980@163.com

Facility:
Name: Qilu Hospital of Shandong University

Address:
City: Jinan
Zip: 250012
Country: China

Contact:
Last name: Lian Liu, Doctor

Phone: 0531-82169851
Email: tounao@126.com

Contact backup:
Last name: Jisheng Li, Doctor

Phone: 0531-82169851

Facility:
Name: Shandong Provincial Hospital Affiliated to Shandong First Medical Universiry

Address:
City: Jinan
Zip: 250012
Country: China

Contact:
Last name: Lei Cong, Doctor
Email: wdconglei@163.com

Facility:
Name: The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)

Address:
City: Jinan
Zip: 250012
Country: China

Contact:
Last name: Jing Liang, Doctor
Email: liangjing0531@163.com

Facility:
Name: The Affiliated Hospital of Qingdao University

Address:
City: Qingdao
Zip: 266000
Country: China

Contact:
Last name: Zimin Liu, Doctor
Email: liuzimin301@126.com

Facility:
Name: Qingdao Municipal Hospital (Group)

Address:
City: Qingdao
Zip: 266011
Country: China

Facility:
Name: Yantai Yuhuangding Hospital

Address:
City: Yantai
Zip: 264000
Country: China

Contact:
Last name: Aina Liu, Doctor
Email: nana4312@sina.com

Start date: November 1, 2022

Completion date: December 31, 2024

Lead sponsor:
Agency: Qilu Hospital of Shandong University
Agency class: Other

Source: Qilu Hospital of Shandong University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05586061