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

NCT05586061 | Active Not Recruiting Phase 2

• 1 other identifier: RCTS
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

HER2-positive Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• objective response rate (ORR)

  The proportion of subjects with complete response (CR) and partial response (PR) in total subjects

  6 months after the last subject participating in

Secondary Outcomes (4)

• progression-free survival (PFS)

  12 months after the last subject participating in

• overall survival (OS)

  12 months after the last subject participating in

• disease control rate (DCR)

  12 months after the last subject participating in

• duration of response (DOR)

  12 months after the last subject participating in

Study Arms (1)

RC48 Plus Tislelizumab and S-1(RCTS)

EXPERIMENTAL

Disitamab Vedotin: 2.5mg/kg, ivdrip, d1, (every 3 weeks) Q3W； Tislelizumab: 200mg, ivdrip, d1, (every 3 weeks) Q3W； S-1: 40-60mg(according to patients' body surface area), po, bid, d1-14 and discontinued for 7 days in each cycle; until progressive disease (PD) or intolerable toxicity

Drug: Disitamab vedotin; Drug: Tislelizumab; Drug: S1

Interventions

Disitamab vedotin DRUG

Disitamab Vedotin: 2.5mg/kg, d1, ivdrip, (every 3 weeks) Q3W

Also known as: RC48

RC48 Plus Tislelizumab and S-1(RCTS)

Tislelizumab DRUG

Tislelizumab: 200mg, d1, ivdrip, (every 3 weeks) Q3W

Also known as: BGB-A317

RC48 Plus Tislelizumab and S-1(RCTS)

S1 DRUG

S-1: 40-60mg (according to patients' body surface area), po, bid, d1-14, discontinued for 7 days.

RC48 Plus Tislelizumab and S-1(RCTS)

Eligibility Criteria

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

You may qualify if:

• Aged18-75 years, gender is not limited;
• Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis;
• HER2 was detected as 2+or 3+ by immunohistochemistry（IHC） ;
• Has at least 1 measurable lesion as determined by RECIST 1.1;
• 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;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Adequate organ function:
• 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；
• 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;
• Kidney function: Blood creatinine (Cr) ≤1.5×ULN or Cockcroft Gault formula ≥ 60 mL/min;
• Cardiac function: New York Heart Association (NYHA) classification\<Grade 3; Left ventricular ejection fraction≥50%;
• The life expectancy is at least 3 months;
• Female of childbearing age must have taken reliable contraceptive measures or conducted a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the trial period and 8 weeks after the last administration of the test drug; For male, they must agree to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the trial drug;
• Willing to join the study and signed an informed consent form (ICF) with good compliance and cooperation in follow-up.

You may not qualify if:

• Allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug;
• Cardiovascular and cerebrovascular events that are not well controlled, such as:
• NYHA grade 2 or above heart failure;
• Unstable angina pectoris;
• Myocardial infarction occurred within 1 year;
• Supraventricular or ventricular arrhythmia with clinical significance needs treatment or intervention;
• Cerebral hemorrhage and cerebral infarction (except for lacunar cerebral infarction without symptoms and without treatment);
• Serious cardiovascular and cerebrovascular events occurred within 12 months;
• Uncontrolled hypertension, i.e. systolic blood pressure\>140 mmHg or diastolic blood pressure\>90 mmHg after single drug treatment;
• 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;
• Stroke event or transient ischemic attack occurred within 12 months before recruitment;
• 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.
• 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.);
• 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;
• 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;

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (7)

Central Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250012, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Shandong Provincial Hospital Affiliated to Shandong First Medical Universiry

Jinan, Shandong, 250012, China

Location

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

Jinan, Shandong, 250012, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

Qingdao Municipal Hospital (Group)

Qingdao, Shandong, 266011, China

Location

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

Location

MeSH Terms

Interventions

disitamab vedotin; tislelizumab; S 1 (combination)

Study Officials

• Lian Liu, Doctor

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

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: October 16, 2022
• First Posted: October 19, 2022
• Study Start: February 10, 2023
• Primary Completion: December 29, 2024
• Study Completion: December 31, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

CN (7)