Thalidomide Combined With Chemotherapy and Monotherapy for Maintenance Treatment for Her2-negative Advanced GC

• Status: Not yet recruiting
• Trial end date: 2024-12-10
• Target enrollment: 0
• Participant gender: All

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. The 5-year survival rate of patients with liver metastases from gastric cancer is very low, making clinical treatment challenging.

Thalidomide has immunomodulatory and anti-angiogenesis effects. It has been used in the treatment of multiple myeloma for more than 20 years, and there are many clinical studies in solid tumors. In recent years, thalidomide has been found to induce the degradation of IKAROS family transcription factors IKZF1 and IKZF3 in combination with CRBN. Therefore, it is very meaningful to explore the therapeutic value of thalidomide in advanced gastric cancer liver metastasis.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qilu Hospital of Shandong University
• Treatments: Thalidomide

Criteria

Inclusion Criteria:

1. Aged 18-75 years old;

2. ECOG physical status score 0-1 points (within 3 days before starting treatment);

3. Expected survival period ≥ 3 months;

4. Basically normal functions of major organs;

5. 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;

6. 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;

7. 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);

8. Measurable lesions assessed according to RECIST1.1;

9. Able to swallow pills normally.

Exclusion Criteria:

1. Those who are allergic to thalidomide;

2. Pregnant or lactating women;

3. Severe mental illness;

4. Those who cannot take medication or follow up as planned;

5. During the trial period and within 3 months after the trial, the subjects and their partners are not willing to use contraception;

6. Participants in other clinical studies 3 months prior to the trial；

7. Patients who are financially well off and willing to use immune checkpoint inhibitors.