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NCT06385873Not yet recruitingPhase 2

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

Disitamab Vedotin Combined With Adebrelimab, Apatinib and S-1 as Neoadjuvant Therapy in Locally Advanced Gastric Cancer With HER2 Overexpression: a Prospective, Phase II Study

Source: ClinicalTrials.gov · Last updated 13 May 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
32 (estimated)
First submitted
24 Apr 2024
Start date
1 May 2024
Primary completion date
1 May 2027
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
NCT number
NCT06385873

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 32
  • From 1 May 2024 to the primary completion date, 1 May 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 1\. Concurrent malignant disease other than gastric cancer (excluding early-stage tumors that have been radically treated);
  • 2\. 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;
  • 4\. 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;
  • 5\. Has had systemic treatment required within 2 years before the first administration of the study medication;
  • 6\. Known allogeneic organ transplantation (except for corneal transplantation);
  • 11\. Received live vaccines within 30 days before the first administration (Day 1 of Cycle 1);

Other illness

  • 7\. Known allergy to any medication used in this study;
  • 9\. Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibodies);
  • 10\. Active hepatitis B or C infection;
  • 13\. Presence of any severe or uncontrollable systemic disease.

Other

  • 8\. Peripheral neuropathy of grade ≥2;
  • 12\. Pregnant or breastfeeding women;

Who the study is looking for

  • 1\. Participants voluntarily join this study, are able to complete the signing of the informed consent form, and have good compliance;
  • 2\. Age between 18 to 75 years old (at the time of signing the informed consent form), with no gender restrictions;
  • 3\. 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;
  • 4\. Have not previously received systemic treatment for the current disease, including anti-tumor chemotherapy/immunotherapy, etc.;
  • 5\. HER2 overexpression confirmed by IHC results from endoscopic biopsy tissue (defined as: IHC 2+, 3+);
  • 6\. ECOG score of 0-1;
  • 7\. Estimated life expectancy of ≥6 months;
  • 8\. Good major organ function:

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.