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Phase II Clinical Study of Adebrelimab and Fruquintinib Combined With Paclitaxel/Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer After First-line Treatment With PD-1 Antibody Failed

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

This is a prospective, single-center, open, single-arm clinical study to observe and evaluate the efficacy and safety of Fruquintinib and Adebrelimab combined with paclitaxel/albumin paclitaxel for second-line treatment of advanced gastric cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years old.

• The ECOG score is 0-1 and does not deteriorate within 7 days.

• Patients with histologically confirmed, metastatic, or unresectable locally advanced gastric cancer or GEJ adenocarcinoma.

• Previously received one systemic chemotherapy regimen for this cancer and progressed; Or have received adjuvant chemotherapy, but have disease progression or recurrence within 6 months after the end of treatment.

• First-line exposure to PD-1 antibodies and first-line treatment of PFS greater than 9 months.

• Measurable lesions that meet RECIST 1.1 criteria.

• Have adequate organ and bone marrow function, laboratory tests meet the following requirements:

∙ HGB≥90g/L;

‣ NEUT≥1.5×10\^9/L;

‣ PLT ≥80×10\^9/L;

‣ TBIL≤1.5 times upper limit of normal value (ULN);

‣ ALT and AST≤2.5 x ULN; In liver metastasis, ALT and AST≤5×ULN;

‣ Endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula);

‣ Urinary protein \< (++), or 24-hour urinary protein volume \< 1.0 g.

• Normal coagulation function, no active bleeding

∙ International standardized ratio INR≤1.5;

‣ Partial thromboplastin time APTT≤1.5 ULN.

• Women of childbearing age must undergo a negative pregnancy test (serum or urine) within 14 days prior to enrollment and voluntarily use an appropriate method of contraception during the observation period and within 8 weeks after the last dose of the study drug; For men, they should be surgically sterilized or consent to an appropriate method of contraception during the observation period and for 8 weeks after the last administration of the study drug.

⁃ Expected survival ≥3 months.

⁃ Patients voluntarily joined the study and signed an informed consent form (ICF).

⁃ It is expected that the compliance is good, and the efficacy and adverse reactions can be followed up according to the protocol requirements.

Locations
Other Locations
China
Tianjin Medical University Cancer Institute and Hospital
RECRUITING
Tianjin
Contact Information
Primary
Ting Deng, MD
xymcdengting@126.com
022-23340123
Backup
Jiayu Zhang, MD
zhangjiayu152@163.com
15201752860
Time Frame
Start Date: 2023-11-10
Estimated Completion Date: 2026-10-10
Participants
Target number of participants: 30
Treatments
Adebrelimab, Fruquintinib combined with paclitaxel
Fruquintinib 4mg d1-14, q3w Paclitaxel 150mg/m2, d1, q3w / Albumin paclitaxel 125mg/m2, d1, d8, q3w PD-L1 antibody (Adebrelimab) 20 mg/kg, d1, q3w
Related Therapeutic Areas
Sponsors
Leads: Tianjin Medical University Cancer Institute and Hospital

This content was sourced from clinicaltrials.gov