Status:
UNKNOWN
A Study of QL1604 Plus Nab-paclitaxel Versus Paclitaxel in Subjects With Advanced Gastric Cancer.
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Conditions:
Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who had tumor progression after first-line treatment with platinum and fluoropyrimidine doublet thera...
Eligibility Criteria
Inclusion
- Volunteer to participate in this clinical study; Completely understand and know this study as well as sign the informed consent form (ICF);
- Age ≥ 18 years and ≤ 80 years when ICF is signed;
- Have histologically or cytologically confirmed diagnosis of locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma(G/GEJC).
- Eastern Cooperative Oncology Group performance status of 0 or 1;
- Life expectancy of at least 12 weeks;
- Have measurable disease as defined by RECIST 1.1 as determined by the investigator;
- Be willing to provide newly-obtained or paraffin-embedded tissue for PD-L1 and other biomarker analysis;
- HER-2/neu negative；
- Female subjects of childbearing potential should have a negative serum human chorionic gonadotropin(HCG) test within 7 days prior to receiving the first dose of study medication and are not breastfeeding;
- Male and female subjects able to have children must agree to use highly effective method of contraception throughout the study and for at least 180 days after last dose.
Exclusion
- Has non-G/GEJC such as squamous cell carcinoma, adenosquamous carcinoma, undifferentiated gastric cancer;
- Known allergy or hypersensitivity to QL1604/nab-paclitaxel/paclitaxel or any components used in the preparation;
- Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease disease-relieving drugs, corticosteroids or immunosuppressant）;
- Has a diagnosis of immunodeficiency or received systemic steroid therapy （\>10mg daily of prednisone or equivalent drug）or any other form of immunosuppressive therapy within 14 days prior to the planned start of study therapy；
- Subjects who have received radiotherapy, chemotherapy, monoclonal antibodies,targeted therapy, other anti-tumor treatments,or participating in other clinical studies is less than 4 weeks before the first dose of trial treatment;
- Has a known additional malignancy that is progressing or requires active treatment in past 3 years;
- Subjects with known central nervous system (CNS) metastasis;
- Has a history of pneumonitis that required steroids in past 3 years;
- Has an active infection requiring systemic therapy；
- Subjects with the history of Human Immunodeficiency Virus (HIV)、acquired, congenital immunodeficiency diseases、organ transplant;
- Has hepatitis B surface antigen (HBsAg) positive and/or hepatitis B core antibody (HBcAb) positive and HBV deoxyribonucleic acid (HBV DNA) \>1000 copies/mL, or hepatitis C virus antibody positive;
- Has received a live vaccine within 30 days of the planned start of study therapy；
- Has received prior immune checkpoint inhibitors;
- Known psychiatric or substance abuse disorders that would interfere with the requirements of the study;
- Subjects with uncontrollable cardiac diseases;
- Has accompanying diseases that seriously endanger the subject's safety or affect the study by the investigator;
- Has any condition that increases the risk, interferes with the study results by the investigator, or investigators/sponsor consider the subjects are not suitable for this trial;
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2022
Estimated Enrollment :
492 Patients enrolled
Trial Details
Trial ID
NCT04435652
Start Date
July 1 2020
End Date
November 30 2022
Last Update
June 17 2020
Active Locations (1)
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1
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 2000 32