RecruitingPhase 2NCT05494060

XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma

XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma, a Randomized, Controlled, Multicenter Clinical Trial


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

80 participants

Start Date

Mar 16, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open label, randomized, phase Ⅱ, multi-cohort study to treat subjects with ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma. The patients will be randomized into two arms consist of Penpulimab + Anlotinib (3 weeks/cycle) + XELOX and XELOX at a ratio of 1:1. This study is conducted to assess safety and anti-tumor activity of the monoclonal antibody Penpulimab in combination with Anlotinib and standard chemotherapy as adjuvant treatment for ctDNA-positive Gastric, or Gastroesophageal Junction Carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding two targeted drugs — anlotinib and penpulimab — to standard chemotherapy (XELOX) after surgery can help prevent stomach or stomach-esophagus junction cancer from coming back in patients whose cancer DNA (ctDNA) is still detectable in the blood after surgery. The presence of ctDNA after surgery suggests a higher risk of relapse. This is an adjuvant (post-surgical) therapy trial. **You may be eligible if...** - You are between 18 and 75 years old with confirmed gastric or gastroesophageal junction cancer - You had radical surgical removal (D2 resection) of your cancer - Your cancer is stage III (based on the 8th AJCC system) - Your ctDNA (circulating tumor DNA in the blood) is detectable after surgery - You are in good health with adequate blood counts, liver, and kidney function **You may NOT be eligible if...** - You have distant spread (metastatic disease) - You have signs of another active cancer - You have serious heart, liver, or kidney problems - You are pregnant or planning pregnancy 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

DRUGAnlotinib hydrochloride capsule

Anlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21);

DRUGPenpulimab Injection

Penpulimab Injection 100mg per bottle, 200mg IV Day 1, cycled every 21 days

DRUGXELOX

Capecitabine:1000 mg/m2 bid d1-14 q3w, Oxaliplatin:130 mg/m2 d1 q3w


Locations(1)

Jiangsu Province Hospital

Nanjing, Jiangsu, China

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NCT05494060


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