Status:
UNKNOWN
Thalidomide Combined With Chemotherapy and Monotherapy for Maintenance Treatment for Her2-negative Advanced GC
Lead Sponsor:
Qilu Hospital of Shandong University
Conditions:
Gastric Cancer Metastatic to Liver
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The overall incidence of liver metastases from gastric cancer is about 9.9%-18.7%. Gastric cancer has strong heterogeneity and rapid disease progression, and the prognosis of liver metastasis is poor....
Detailed Description
The overall incidence of liver metastases from gastric cancer is about 9.9%-18.7%. Gastric cancer has strong heterogeneity and rapid disease progression, and the prognosis of liver metastasis is poor....
Eligibility Criteria
Inclusion
- Aged 18-75 years old;
- ECOG physical status score 0-1 points (within 3 days before starting treatment);
- Expected survival period ≥ 3 months;
- Basically normal functions of major organs;
- Pathologically confirmed metastatic gastric cancer or adenocarcinoma at the gastroesophageal junction with no chance of radical surgery, accompanied by liver metastasis or simple liver metastasis;
- No previous medical treatment; If neoadjuvant or adjuvant chemotherapy has been performed before and after surgery, recurrence can be defined as first-line therapy only after drug withdrawal for at least six months;
- HER2 negative. HER2 negative definition: IHC (0 or 1+), or IHC (2+) but negative for FISH (HER2:CEP17\<2 with mean HER2 copy number \<4.0 signals/cell);
- Measurable lesions assessed according to RECIST1.1;
- Able to swallow pills normally.
Exclusion
- Those who are allergic to thalidomide;
- Pregnant or lactating women;
- Severe mental illness;
- Those who cannot take medication or follow up as planned;
- During the trial period and within 3 months after the trial, the subjects and their partners are not willing to use contraception;
- Participants in other clinical studies 3 months prior to the trial；
- Patients who are financially well off and willing to use immune checkpoint inhibitors.
Key Trial Info
Start Date :
March 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 10 2024
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT05198856
Start Date
March 10 2022
End Date
December 10 2024
Last Update
January 20 2022
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