RecruitingPhase 3NCT06925243

Neoadjuvant Apatinib Combined With Sintilimab and Perioperative SOX Versus Neoadjuvant Sintilimab Combined With Perioperative SOX for Intestinal Type of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

Neoadjuvant Apatinib Combined With Sintilimab and Perioperative SOX Versus Neoadjuvant Sintilimab Combined With Perioperative SOX for Intestinal Type of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: A Prospective, Multicenter, Open-Label, Randomized Controlled Phase III Study


Sponsor

Zuoyi Jiao

Enrollment

682 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to compare the efficacy and safety of neoadjuvant apatinib combined with sintilimab and perioperative SOX chemotherapy versus neoadjuvant sintilimab combined with perioperative SOX chemotherapy in locally advanced intestinal-type gastric cancer/gastroesophageal junction adenocarcinoma. The primary questions include: 1. Whether the complete remission rate (pCR) of the apatinib combined with sintilimab and SOX regimen is higher than that of the sintilimab combined with SOX regimen. 2. The safety of the apatinib combined with sintilimab and SOX regimen. Participants will be divided into: 1. Experimental Group: Participants will receive an intravenous injection of sintilimab (200 mg) combined with the SOX regimen (oxaliplatin 130 mg/m² and S-1, with the initial dose determined based on body surface area). Additionally, apatinib (250 mg) will be administered orally once daily during the first three neoadjuvant cycles. 2. Control Group: Participants will receive treatment with the sintilimab combined with the SOX regimen. This treatment will be administered for three to four cycles prior to surgery, followed by radical surgery, including D2 or D2+ lymph node dissection. Surgery is scheduled four weeks after the last neoadjuvant therapy (NAT) cycle. Within 3 to 6 weeks post-surgery, patients will begin adjuvant SOX chemotherapy. Postoperative patients will receive four cycles of adjuvant SOX chemotherapy, administered every three weeks.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two pre-surgery (neoadjuvant) treatment combinations for patients with locally advanced stomach or gastroesophageal junction cancer (the junction where the stomach meets the food pipe). One group receives anti-angiogenic therapy (apatinib) plus immunotherapy and chemotherapy; the other receives immunotherapy plus chemotherapy only. **You may be eligible if...** - You are between 18 and 75 years old - You have locally advanced gastric or gastroesophageal junction cancer confirmed by biopsy that has not been treated yet (stages cT2–T4, no evidence of spread) - Your cancer is HER2-negative and classified as intestinal-type - Your general health is good enough for surgery (ECOG 0–1) **You may NOT be eligible if...** - Your cancer has spread to distant organs (M1) - Your cancer is HER2-positive - You have previously received any treatment for this cancer - You have poor organ function or major heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNeoadjuvant apatinib combined with sintilimab and perioperative SOX

Sintilimab: 200mg, iv, day 1 Oxaliplatin: 130 mg/m², iv, day 1 S-1: 40-60 mg/m², po, day 1-14 (BSA \< 1.25 m², 40 mg bid, 1.25 m² ≤ BSA \< 1.5 m², 50 mg bid, BSA ≥ 1.5 m², 60 mg bid) Apatinib: 250mg, po, day1-21, for 3 cycles preoperatively

DRUGNeoadjuvant sintilimab combined with perioperative SOX

Sintilimab: 200mg, iv, day 1 Oxaliplatin: 130 mg/m², iv, day 1 S-1: 40-60 mg/m², po, day 1-14 (BSA \< 1.25 m², 40 mg bid, 1.25 m² ≤ BSA \< 1.5 m², 50 mg bid, BSA ≥ 1.5 m², 60 mg bid)


Locations(4)

First Hospital of Lanzhou University

Lanzhou, Gansu, China

Gansu Provincial Hospital

Lanzhou, Gansu, China

Lanzhou University Second Hospital

Lanzhou, Gansu, China

The Gastrointestinal Surgery Department, Sun Yat-sen University Cancer Center Gansu Hospital

Lanzhou, Gansu, China

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NCT06925243


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