RecruitingPhase 2NCT05739045

Nivolumab Combined With SOX Used in the Perioperative Treatment

A Multicenter, Prospective, Phase Ⅱ Clinical Study of Nivolumab Combined With SOX in the Perioperative Treatment of Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma


Sponsor

Xiangdong Cheng

Enrollment

46 participants

Start Date

Nov 3, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the pathological complete response rate (pCR) of nivolumab combined with SOX (oxaliplatin + S-1) for neoadjuvant therapy of resectable gastric and gastroesophageal junction adenocarcinoma;


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding nivolumab (an immunotherapy drug) to a standard chemotherapy regimen (SOX: S-1 plus oxaliplatin) given before and after surgery can improve outcomes for people with stomach or gastroesophageal junction cancer that is surgically removable. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with stomach cancer or cancer at the junction of the stomach and esophagus, confirmed by biopsy - Your cancer is at a locally advanced stage (T3–T4 or involves lymph nodes) but has not spread to distant organs - You have not received any prior cancer treatment - Your general health is good (ECOG score 0–1) - You are able to swallow tablets - Your blood, liver, and kidney functions are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to other parts of the body - You have had previous surgery, radiation, or chemotherapy for this cancer - You have serious autoimmune conditions or active infections - Your organ function does not meet required thresholds 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

DRUGnivolumab combined with SOX

nivolumab + SOX (3 cycles) before surgery → radical surgery (D2) → nivolumab + SOX (3 cycles) after surgery → nivolumab monotherapy maintenance (11 cycles);


Locations(1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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NCT05739045


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