RC48 Combined With Adebrelimab, Apatinib and S-1 as Neoadjuvant Therapy in Locally Advanced Gastr… (NCT06385873) | Clinical Trial Compass
Not Yet RecruitingPhase 2
RC48 Combined With Adebrelimab, Apatinib and S-1 as Neoadjuvant Therapy in Locally Advanced Gastric Cancer
32 participantsStarted 2024-05-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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:
Exclusion Criteria:
* 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 …
What they're measuring
1
Pathological Complete Response Rate (pCR)
Timeframe: 4 months
Trial details
NCT IDNCT06385873
SponsorThe First Affiliated Hospital with Nanjing Medical University