Status:
ENROLLING_BY_INVITATION
Association of Nutritional Status With Immune Checkpoint Inhibitor Efficacy in Metastatic Metastatic Esophagogastric Cancer.
Lead Sponsor:
Yongxu Jia
Conditions:
Gastric Neoplasm
Esophageal Adenosquamous Carcinoma
Eligibility:
All Genders
18+ years
Brief Summary
In patients with advanced gastrointestinal cancers, malnutrition can lead to increased incidence of adverse events during the peri-chemoradiotherapy period, reduced treatment tolerance, lower completi...
Eligibility Criteria
Inclusion
- Histologically confirmed esophageal squamous carcinoma and gastric adenocarcinoma, metastatic disease.
- Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
- Karnofsky performance status ≥80
- Life expectancy of ≥ 3 month
- WBC \> 3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet \> 100,000/mm3, Hb \> 9g/dl(within 14 days before enrollment),ALT and AST \< 2.5 times ULN (≤5 times ULN in patients with liver metastases),Bilirubin level \< 1.0 times ULN,Serum AKP \< 2.5 times ULN,Serum creatinine \< 1.5 times ULN
- No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever \> 38℃；
- Normal ECG and heart function
- Fertile patients must use effective contraception
- Good compliance
Exclusion
- Previous treatment of palliative chemotherapy
- Only with Brain or bone metastasis
- No measurable lesions, eg. pleural fluid and ascites
- Suffer from severe heart disease or disease with other important organs
- Chronic diarrhea or renal dysfunction
- Pregnancy or lactation period
- Other previous malignancy within 5 year, except non-melanoma skin cancer Chronic diarrhea
- Mentally abnormal or disable cognition,including CNS metastasis
Key Trial Info
Start Date :
October 31 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06923020
Start Date
October 31 2024
End Date
October 31 2027
Last Update
April 11 2025
Active Locations (1)
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1
Yongxu Jia
Zhengzhou, Henan, China, 450000