RecruitingPhase 2NCT06791148

Low-dose Radiotherapy Combined With Chemotherapy and AK112 as Second-line Treatment in Patients With Advanced G/GEJ Cancer

Low-dose Radiotherapy Combined With Albumin-bound Paclitaxel and AK112 as Second-line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction(G.GEJ)Cancer Who Failed First-line Therapy:a Single,Phase II Trial


Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Enrollment

45 participants

Start Date

Jul 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The study aims to evaluate the efficacy and safety of the combination of albumin-bound paclitaxel and AK112 with low-dose radiotherapy in patients with gastric adenocarcinoma and gastroesophageal junction adenocarcinoma who have failed first-line standard therapy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining low-dose radiation with chemotherapy and AK112 (an immunotherapy drug that targets two proteins cancer uses to hide from the immune system) works better than current second-line options for people with advanced stomach or gastroesophageal junction cancer that stopped responding to first-line treatment. **You may be eligible if...** - You are between 18 and 75 years old - You have advanced gastric (stomach) or gastroesophageal junction adenocarcinoma confirmed by tissue test - Your cancer has stopped responding to first-line (standard initial) treatment - You have at least one measurable tumor on a scan - Your expected survival is at least 6 months - Your organ function meets required minimums **You may NOT be eligible if...** - You have not yet tried first-line treatment - You do not have measurable disease - Your performance status or organ function does not meet requirements - You are pregnant or not using contraception 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

RADIATIONLow-dose radiotherapy

2Gy/f,q3w,×4f

DRUGalbumin-bound paclitaxel

100-120mg/m2,i.v.,d2,d9,q3w

DRUGAK112

20mg/kg, i.v., d2, q3w


Locations(1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

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NCT06791148


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