RC48 Combined With Adebrelimab, Apatinib and S-1 as Neoadjuvant Therapy in Locally Advanced Gastric Cancer

NCT06385873 | Not Yet Recruiting Phase 2

• 1 other identifier: 2024-SR-233
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a prospective, open-label, phase II clinical trial that aims to enroll patients with locally advanced gastric adenocarcinoma who have not received any prior treatment and are candidates for surgery. The study drugs include RC48, Adebrelimab, Apatinib and S-1. The purpose is to evaluate the effectiveness and safety of the combined coordinated treatment of multi-mechanism drugs for perioperative treatment of locally advanced gastric cancer with HER2 overexpression.

Conditions

Gastric Cancer/Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response Rate (pCR)

  Defined as the proportion of subjects with no residual viable tumor cells on microscopy and negative lymph nodes out of the total number of subjects;

  4 months

Secondary Outcomes (4)

• Major Pathological Response rate (MPR)

  4 months

• R0 Resection rate

  4 months

• Disease-Free Survival (DFS）

  24 months

• Overall Survival (OS)

  36 months

Study Arms (1)

Experimental

EXPERIMENTAL

RC48, Adebrelimab, Apatinib and S-1 regimen for 3-4 cycles (every 3 weeks) before surgery.

Drug: RC48; Drug: Adebrelimab; Drug: Apatinib; Drug: S-1

Interventions

RC48 DRUG

RC48: 2.5 mg/kg, intravenous infusion, on day 1, every 3 weeks (Q3W);

Also known as: Disitamab Vedotin

Experimental

Adebrelimab DRUG

Adebrelimab：1200 mg, intravenous infusion, on day 1, every 3 weeks (Q3W);

Experimental

Apatinib DRUG

Apatinib: 250mg, oral administration, once daily (qd), every 3 weeks (Q3W);

Experimental

S-1 DRUG

S-1：For patients with a body surface area (BSA) ≤1.5m², use 50mg each time; for patients with BSA \>1.5m², use 60mg each time, oral administration, twice daily (bid), on days 1-14, every 3 weeks (Q3W);

Also known as: S-1tegafur, gimeracil and oteracil potassium

Experimental

Eligibility Criteria

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

You may qualify if:

• \. Participants voluntarily join this study, are able to complete the signing of the informed consent form, and have good compliance;
• \. Age between 18 to 75 years old (at the time of signing the informed consent form), with no gender restrictions;
• \. Gastrointestinal cancer or gastroesophageal junction adenocarcinoma confirmed by histology and/or cytology, diagnosed as locally advanced according to the 8th edition of the AJCC standards, with a cTNM diagnosis of T3-4aN+M0 and T4aNanyM0 based on ultrasound endoscopy or enhanced CT/MRI scan (and diagnostic laparoscopy if necessary), and agree to receive curative surgical treatment, with the investigator assessing the potential for tumor resectability;
• \. Have not previously received systemic treatment for the current disease, including anti-tumor chemotherapy/immunotherapy, etc.;
• \. HER2 overexpression confirmed by IHC results from endoscopic biopsy tissue (defined as: IHC 2+, 3+);
• \. ECOG score of 0-1;
• \. Estimated life expectancy of ≥6 months;
• \. Good major organ function:

You may not qualify if:

• \. Concurrent malignant disease other than gastric cancer (excluding early-stage tumors that have been radically treated);
• \. Tumor lesions with a tendency to bleed (such as active ulcerative tumor lesions with positive fecal occult blood test, history of hematemesis or melena within 2 months before signing the informed consent form, or assessed by the investigator as being at risk of significant gastrointestinal hemorrhage, etc.) or having received blood transfusion treatment within 4 weeks before the study medication; 3. Inability to take oral medication;
• \. Currently participating in another interventional clinical study treatment, or having received other investigational drugs or used investigational medical devices within 4 weeks before the first administration of the study medication;
• \. Has had systemic treatment required within 2 years before the first administration of the study medication;
• \. Known allogeneic organ transplantation (except for corneal transplantation);
• \. Known allergy to any medication used in this study;
• \. Peripheral neuropathy of grade ≥2;
• \. Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibodies);
• \. Active hepatitis B or C infection;
• \. Received live vaccines within 30 days before the first administration (Day 1 of Cycle 1);
• \. Pregnant or breastfeeding women;
• \. Presence of any severe or uncontrollable systemic disease.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

disitamab vedotin; apatinib; S 1 (combination); gimeracil; potassium oxonate

Condition Hierarchy (Ancestors)

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

Study Officials

• Xiaofeng Xiaofeng, Ph.D

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Hao Xu, Ph.D

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaofeng Chen, Ph.D

CONTACT

13585172066; chenxiaofengnjmu@163.com

Hao Xu, Ph.D

CONTACT

13851530117; 66881866@qq.com

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: April 24, 2024
• First Posted: April 26, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share