Status:
TERMINATED
Nab-paclitaxel Plus PD-1 Inhibitor Versus Nab-paclitaxel As Second-line Treatment in Advanced Gastric Cancer
Lead Sponsor:
Huazhong University of Science and Technology
Conditions:
Gastric Cancer
GastroEsophageal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a Multi-center, Open-label, Randomized Controlled,phase 2 clinical trail of Albumin-bound Paclitaxel Plus SHR-1210 （PD-1 inhibitor）Versus Albumin-bound Paclitaxel as Second-line Treatment in A...
Detailed Description
This is a Multi-center, Open-label, Randomized Controlled,phase 2 clinical trail of an immune checkpoint inhibitor in patients with advanced or recurrent gastric and esophagogastric junction adenocarc...
Eligibility Criteria
Inclusion
- Age of 18-70 years.
- Second line treatment for cytological or histological diagnosis of recurrent or metastatic gastric and esophagogastric adenocarcinoma. Disease progression after adjuvant therapy within 6 months is eligible.
- ECOG performance status of 0-2.
- Estimated life expectancy of at least 3 months.
- Bone marrow function: white blood cell count≥3.0×109 /L, absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT) ≥90×109 /L, hemoglobin(HB) ≥90 g/L.
- Left ventricular ejection fraction (LVEF) ≥ 50%.
- Liver and kidney function: Creatinine(Cr)≤1.5 x upper limit of normal range(ULN); alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN), or ≤5 x upper limit of normal range (ULN)when with hepatic metastases，total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN), or≤2.5 x upper limit of normal range (ULN) when with Gilbert's syndrome.
- Any acute, clinically significant treatment-related toxicity caused by previous treatment must have been reduced to less than or equal to grade 1, except hair loss.
- Able and willing to comply with the study plans in this protocol and sign the informed consent.
Exclusion
- uncontrollable infections or have received systematic antibiotic treatment within 72 hours before enrollment.
- Any abnormal bone marrow hyperplasia or other abnormal hematopoietic function.
- Have a second malignancy within 5 years prior to registration except for cured carcinoma in situ of cervix uteri, non-melanoma skin cancer.
- Patients with symptomatic brain metastases.
- Allergic to the chemotherapy drugs or the materials in this study.
- Suffering from mental or nervous system disorders and unable to cooperate.
- Pregnant or nursing female patients. Men and women of reproductive age are unwilling to take reliable contraceptive measures during the study.
- Active autoimmune disease, history of autoimmune disease, use of corticosteroids or immunosuppressants, or use of hormone replacement therapy, such as thyroxine, insulin, etc.
- Live vaccine was administered within 30 days before enrolment (injectable seasonal influenza vaccine is allowed as it is inactivated).
- Patients with other diseases not suitable for enrolment, such as active tuberculosis, hepatitis B (after treatment, hepatitis B virus titer HBV-DNA \<500IU/ml, and liver function is normal, but cannot be combined with hepatitis C), hepatitis C, uncontrolled electrolyte disorders ,pericardial effusion, pleural effusion and abdominal effusion, etc.
- Have participated in other clinical trials within 30 days prior to this study.
- History of organ transplantation.
- Patients that researcher consider cannot sign informed consent or complete the study.
Key Trial Info
Start Date :
April 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04294784
Start Date
April 3 2020
End Date
November 30 2023
Last Update
November 4 2024
Active Locations (1)
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1
Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030