Nab-paclitaxel Plus PD-1 Inhibitor Versus Nab-paclitaxel as Second-line Treatment in Advanced Gastric Cancer
Study Details
Study Description
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 Advanced or Recurrent Gastric Adenocarcinoma
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
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 adenocarcinoma, including two arms to compare the efficacy and safety of Albumin-bound Paclitaxel Plus SHR-1210 (PD-1 inhibitor)regimen and Albumin-bound Paclitaxel single-agent regimen in second-line treatment.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Nab-P/PD-1 Patients in this arm receive albumin-bound paclitaxel and SHR-1210 (PD-1 inhibitor) thepary. |
Drug: Albumin-bound Paclitaxel Plus SHR-1210 (PD-1 inhibitor)
Albumin-bound Paclitaxel 100 mg/m2,ivdrip,d1,d8,d15,Q28d,or Albumin-bound Paclitaxel 125-130 mg/m2,ivdrip,d1,d8,Q21d,or Albumin-bound Paclitaxel 260mg/m2,ivdrip,d1,Q21d;SHR-1210 200mg, ivdrip,d1,Q21d.
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Active Comparator: Nab-P Patients in this arm receive albumin-bound paclitaxel single-agent chemotherapy. |
Drug: Albumin-bound Paclitaxel
Albumin-bound Paclitaxel 100 mg/m2,ivdrip,d1,d8,d15,Q28d,or Albumin-bound Paclitaxel 125-130 mg/m2,ivdrip,d1,d8,Q21d,or Albumin-bound Paclitaxel 260mg/m2,ivdrip,d1,Q21d;
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Outcome Measures
Primary Outcome Measures
- objective response rate(ORR) [up to 12 months]
The rate of participants that achieve either a complete response (CR) or a partial response (PR).Higher rate of ORR indicates better treatment effect.
Secondary Outcome Measures
- Progression-free Survival (PFS) [up to 9 months]
Time from the start of treatment to progression of disease or death.Higher rate of 9m PFS in statistic analysis means better outcome.
- Overall survival (OS) [up to 12 months]
Time from the start of treatment until death due to any reason.Increased rate of 12m OS compared to the other arm indicates more benefit from the treatment regimen.
- Safety as measured by number and grade of adverse events [up to 12 months]
Summary adverse events according to NCI-CTCAE 5.0
- patient-reported outcomes (PROs) [up to 12 months]
Patient-reported outcomes according to EQ-5D questionnaires.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age of 18-70 years.
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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.
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ECOG performance status of 0-2.
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Estimated life expectancy of at least 3 months.
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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.
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Left ventricular ejection fraction (LVEF) ≥ 50%.
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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.
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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.
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Able and willing to comply with the study plans in this protocol and sign the informed consent.
Exclusion Criteria:
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uncontrollable infections or have received systematic antibiotic treatment within 72 hours before enrollment.
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Any abnormal bone marrow hyperplasia or other abnormal hematopoietic function.
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Have a second malignancy within 5 years prior to registration except for cured carcinoma in situ of cervix uteri, non-melanoma skin cancer.
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Patients with symptomatic brain metastases.
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Allergic to the chemotherapy drugs or the materials in this study.
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Suffering from mental or nervous system disorders and unable to cooperate.
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Pregnant or nursing female patients. Men and women of reproductive age are unwilling to take reliable contraceptive measures during the study.
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Active autoimmune disease, history of autoimmune disease, use of corticosteroids or immunosuppressants, or use of hormone replacement therapy, such as thyroxine, insulin, etc.
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Live vaccine was administered within 30 days before enrolment (injectable seasonal influenza vaccine is allowed as it is inactivated).
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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.
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Have participated in other clinical trials within 30 days prior to this study.
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History of organ transplantation.
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Patients that researcher consider cannot sign informed consent or complete the study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | China | 430030 |
Sponsors and Collaborators
- Huazhong University of Science and Technology
Investigators
- Study Chair: Xianglin Yuan, MD,PhD, oncology center of Tongji Hospital,wuhan,China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TJCC011