Advanced gastric cancer
Conditions
Interventions
Trial group:Induction therapy phase: QL1706 (5 mg/kg, IV, Q3W) in combination with nab-paclitaxel (80 mg/m2, IV, Days 1 and 8, Q3W) and lenvatinib (8 mg, PO, QD), administered for 6 months per this re
Sponsors
The affiliated hospital of Qingdao university
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Written and signed informed consent form 2. Age >=18 years and =3 months 5. Histologically or cytologically confirmed advanced unresectable or metastatic gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma 6. At least one measurable lesion according to RECIST v1.1 7. Failure of first-line systemic therapy for gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma, and disease recurrence within <=6 months after prior neoadjuvant or adjuvant therapy 8. Normal organ function 9. Agreement to use effective contraception from the date of signing informed consent until 120 days after the last dose of study drug
Exclusion criteria
Exclusion criteria: 1. Other invasive malignancies within 3 years, except locally curable malignancies such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical cancer, or carcinoma in situ of the breast 2. Prior systemic therapy targeting the VEGF or anti-VEGFR signaling pathway 3. Prior exposure to anti-CTLA-4 antibody, or any other antibody or drug targeting T-cell co-stimulation or checkpoint pathways, except PD-1 or PD-L1, such as ICOS or agonists (e.g., CD40, CD137, GITR, and OX40) 4. History of primary immunodeficiency viral infection 5. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation 6. History of interstitial lung disease 7. History of active tuberculosis 8. Central nervous system (CNS) metastases, leptomeningeal disease, spinal cord compression, or meningeal disease 9. Patients with untreated chronic hepatitis B or HBV DNA >2000 IU/mL, or active hepatitis C should be excluded. Patients who are HCV antibody-positive are eligible if HCV RNA testing is negative 10. Known history of positive human immunodeficiency virus (HIV) testing 11. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage 12. Active, known, or suspected autoimmune disease, or history of autoimmune disease, except for the following: vitiligo, alopecia, severe disease, psoriasis, or eczema not requiring systemic therapy within the past 2 years; hypothyroidism (due to autoimmune thyroiditis) requiring only stable dose hormone replacement therapy; type 1 diabetes requiring only stable dose insulin replacement therapy; or completely resolved childhood asthma, no intervention needed in adulthood, or primary disease that does not recur unless triggered by external factors 13. Pregnant or lactating women 14. Patients deemed unsuitable for enrollment by the investigator for safety or scientific reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall Survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactLiu Zimin
The affiliated hospital of Qingdao university
Outcome results
None listed