RecruitingPhase 2NCT06555471

A Single-arm, Phase II Exploratory Study of Sintilimab in Combination With Chemoradiotherapy in Elderly Patients With Locally Advanced Gastric Cancer


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

40 participants

Start Date

Aug 6, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is a prospective, single-arm, single-centre, phase II clinical study to explore the efficacy and safety of sintilimab in combination with chemoradiation in subjects over 75 years of age with advanced gastric cancer. Participants will: Take sintilimab (200mg iv q3w d1) combined with chemoradiation. The application of chemotherapy based on investigator's assessment, and if so, S-1 (po d1-d14,q3w; according to body surface area :\<1.5m\^2 40mg/time;1.5\~1.8m\^2 50mg/time;\>1.8m2 60mg/time) or capecitabine (1000mg/m2 Bid po d1-14,q3w,Reduce or discontinue depending on the condition of the subject.); Radiotherapy:once a day, five times a week, at a dose of 1.8-2 Gy/f, for a total of 45-50.4 Gy. Radiation therapy starts from the first cycle of Sintilimab Injection combined with chemotherapy. Subjects undergo an initial assessment of imaging, physical status, quality of life, and relevant laboratory tests after completion of 3 cycles of sintilimab combination chemotherapy, followed by assessments every 2 months, and after 3 full assessments, assessments every 3 months are initiated.


Eligibility

Min Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of immunotherapy (sintilimab) with chemotherapy and radiation for elderly patients (75 and older) with locally advanced stomach cancer or cancer of the junction between the stomach and esophagus that cannot be surgically removed. It is a Phase II exploratory study in China. **You may be eligible if...** - You are 75 years of age or older - You have been diagnosed with locally advanced gastric or gastroesophageal junction cancer confirmed by biopsy - Your cancer is HER-2 negative - You have at least one measurable tumor - Your blood counts, liver, kidney, and thyroid function are within acceptable limits - Your overall health allows you to handle treatment (ECOG performance score 0–2) **You may NOT be eligible if...** - You have active autoimmune disease - You are taking systemic steroids or immunosuppressive drugs - You have active hepatitis B or C, or HIV - You have received prior immunotherapy - You have uncontrolled 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

DRUGSintilimab

Sintilimab: 200mg iv q3w d1

DRUGS-1

po d1-d14,q3w; according to body surface area :\<1.5m\^2 40mg/time;1.5\~1.8m\^2 50mg/time;\>1.8m2 60mg/time)

DRUGCapecitabine

1000mg/m2 Bid po d1-14,q3w,Reduce or discontinue depending on the condition of the subject.

RADIATIONExtraperitoneal radiation therapy

once a day, five times a week, at a dose of 1.8-2 Gy/f, for a total of 45-50.4 Gy. Radiation therapy starts from the first cycle of Sintilimab Injection combined with chemotherapy


Locations(1)

Jiangsu Province Hospital

Nanjing, Jiangsu, China

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NCT06555471


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