RecruitingPhase 2NCT06341595

Concurrent Chemoradiotherapy Combined With Sintilimab as Neoadjuvant Therapy for GC Patients With PALM

Concurrent Chemoradiotherapy Combined With Sintilimab as Neoadjuvant Therapy for Advanced Gastric Cancer Patients With Para-aortic Lymph Node Metastasis: a Single-arm, Phase II, Exploratory Study.


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

40 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is a prospective, single arm, single center, phase II clinical study aimed at subjects with advanced gastric cancer and para aortic lymph node metastasis, exploring the feasibility and safety of Sintilimab Injection combined with synchronous chemo-radiotherapy as neoadjuvant therapy. Patients will receive sintilimab Injection (200mg iv q3w d1) combined with concurrent radiotherapy and chemotherapy. The chemotherapy regimen will use oxaliplatin 130mg/m2+S-1 40mg/m2 bid d1-14. Radiotherapy is performed using intraperitoneal 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 (60-66 Gy for lymph node lesions). Radiation therapy starts from the second cycle of Sintilimab Injection combined with chemotherapy. The subjects underwent imaging evaluation after completing 4 cycles of combination chemotherapy and radiation therapy with Sintilimab Injection. Evaluated as a surgical subject (surgical conditions: imaging evaluation of enlarged lymph nodes adjacent to the abdominal aorta with PR or no significant activity), radical surgery will be performed within 4 weeks after the last study drug treatment. After surgery, the researcher will determine the necessity of adjuvant treatment and develop an adjuvant treatment plan based on the subject's condition. Subjects evaluated as inoperable will have their best follow-up treatment plan determined by the researcher.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding immunotherapy (sintilimab) to chemotherapy and radiation therapy before surgery can help patients with stomach or stomach-esophagus junction cancer that has spread to nearby lymph nodes near the large blood vessels of the abdomen — making the cancer technically inoperable at first. **You may be eligible if...** - You are between 18 and 75 years old with confirmed stomach or gastroesophageal junction cancer - Your cancer has spread only to para-aortic lymph nodes (near the main abdominal artery) and nowhere else - You have never received any cancer treatment before - You have had a procedure to confirm no cancer in the abdominal lining or liver - You are generally active (good performance status) with adequate blood, liver, and kidney function **You may NOT be eligible if...** - Your cancer has spread beyond para-aortic lymph nodes (e.g., to the liver or abdominal lining) - You have previously received cancer treatment of any kind - You have serious organ dysfunction or uncontrolled infections - You are pregnant or breastfeeding 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, 4-6 cycles

RADIATIONExtraperitoneal radiation therapy

Radiotherapy using extraperitoneal radiation therapy, once a day, 5 times a week, 1.8-2 Gy/f, a total of 45-50.4 Gy (lymph node lesion radiation dose of 60-66 Gy)

DRUGOxaliplatin

oxaliplatin: 130mg/m\^2, D1, Q3W, 4-6 cycles

DRUGS-1

S-1: 40mg/m\^2, bid, d1-14, 4-6 cycles


Locations(1)

Jiangsu Province Hospital

Nanjing, Jiangsu, China

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NCT06341595


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