An Open-label, Single-arm, Multicenter, Phase II Clinical Study of the Efficacy and Safety of Sequential AG and mFOLFOX Combined With Serplulimab Injection and Bevacizumab Injection in Patients With Untreated Advanced Pancreatic Cancer
Overview
- Phase
- Phase 2
- Intervention
- Sequential AG and mFOLFOX in Combination With Serplulimab Injection and Bevacizumab Injection
- Conditions
- Non-Resectable Pancreas Carcinoma
- Sponsor
- Zhejiang Cancer Hospital
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Objective response rate(ORR)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
It is a single arm, open-label, multicenter, phase II cinical trial to evaluate the efficacy and safety of the Sequential AG and mFOLFOX in Combination With Serplulimab Injection and Bevacizumab Injection in first-line treatment of patients with Advanced or Metastatic Pancreatic Cancer.
Detailed Description
It is a single arm, open-label, multicenter, phase II cinical trial to evaluate the efficacy and safety of the Sequential AG and mFOLFOX in Combination With Serplulimab Injection and Bevacizumab Injection in first-line treatment of patients with Advanced or Metastatic Pancreatic Cancer. A Simon two-stage study design was utilized. Treatment will continue until disease progression or toxicity is intolerable. The plan is to enroll 37 subjects in multiple hospitals in china.
Investigators
Ying Jieer
Chief physician
Zhejiang Cancer Hospital
Eligibility Criteria
Inclusion Criteria
- •Voluntarily agree to participate in the study and sign the informed consent;
- •≥18 years of age and ≤75 years of age on the day of signing the informed consent form, regardless of gender;
- •Pancreatic ductal adenocarcinoma confirmed by pathologic histology or cytology;
- •No prior systemic therapy for unresectable locally advanced or metastatic pancreatic cancer;
- •Measurable lesions at baseline according to RECIST 1.1 criteria; if the subject has only 1 measurable lesion at baseline, the area of the lesion must not have received radiotherapy in the past or there must be evidence of significant progression of the lesion after completion of radiotherapy treatment;
- •the ECOG physical status score was 0 or 1 and the Expected survival ≥12 weeks;
- •No serious organic diseases of the heart, lungs, brain and other organs;
- •Adequate organ function
- •Bone Marrow Function: (no transfusion within 14 days prior to screening, no use of granulocyte colony stimulating factor \[G-CSF\], no use of drug correction) : i. Hemoglobin ≥90g/L; ii. Leukocytes ≥ 4.0 x 109/L, Neutrophils ≥1.5×109/L; iii. Platelet ≥80×109/L;
- •Coagulation function: PT or APTT ≤ 1.5 x ULN in subjects not receiving anticoagulation; if subjects are receiving anticoagulation, as long as the PT is within the range of the anticoagulant drug formulation;
Exclusion Criteria
- •subjects with clear brain metastases on imaging or with meningeal metastases;
- •untreated spinal compression fractures not treated by surgery and/or radiotherapy; treated spinal compression fractures require disease stabilization for at least 2 weeks prior to enrollment;
- •high risk of gastrointestinal or abdominal bleeding as evaluated by the Investigator;
- •uncontrolled cancer pain; narcotic analgesics not at a stable dose at enrollment;
- •previous treatment with vascular endothelial growth factor (VEGFR) inhibitors or previous treatment with immune checkpoint inhibitors;
- •antitumor treatment with chemotherapy, small molecule inhibitors, immunotherapy (e.g., interleukin, interferon, or thymosin) within 28 days prior to enrollment in this study, and herbal medicine with antitumor indications within 14 days prior to dosing;
- •major surgical procedures \[such as transabdominal, transthoracic and other major surgeries; excluding diagnostic puncture such as ultrasonic endoscopy-guided pancreatic fine-needle aspiration biopsy (EUS-FNB), percutaneous hepatic perforation biopsy, peripheral venous catheterization, and biliary stent implantation\] or invasive treatments or operations with incomplete healing of the surgical incision, local anti-tumor treatment such as hepatic artery interventional embolization, hepatic metastasis cryo-ablation, radiofrequency ablation and other local anti-tumor treatments. radiofrequency ablation and other local antitumor therapy;
- •have received radical radiotherapy within 3 months prior to study entry; palliative radiotherapy 2 weeks prior to dosing is permitted, and the dose of radiotherapy meets local standards of care for palliative care;
- •required systemic corticosteroid (\>10 mg/day prednisone or equivalent of other corticosteroid for ≥7 consecutive days) or immunosuppressive therapy within 14 days prior to enrollment in this study; with the exception of inhaled or locally applied hormones, or physiologic replacement doses of hormone therapy due to adrenal insufficiency; short-term (≤7 days) corticosteroids are allowed for prophylaxis (e.g., contrast allergy) or treatment of Non-autoimmune conditions (eg, delayed hypersensitivity reactions caused by exposure to allergens) ;
- •subjects with uncorrectable albumin decline (serum albumin \<3.0 g/dL) 14 days prior to enrollment in this study; and
Arms & Interventions
Sequential AG and mFOLFOX in Combination With Serplulimab Injection and Bevacizumab Injection
Nab-paclitaxel:125 mg/m2, ivgtt, D1, 8 and 15,every 6 weeks for a treatment cycle Gemcitabine hydrochloride: 1g/m2, ivgtt, D1, 8 and 15,every 6 weeks for a treatment cycle 5-FU: 2400 mg/m2 ,ivgtt over 46h, D29-30, every 6 weeks for a treatment cycle Oxaliplatin: 85 mg/m2 ,ivgtt, D29, every 6 weeks for a treatment cycle LV: 400 mg/m2 ,ivgtt over 2h, D29, every 6 weeks for a treatment cycle Serplulimab Injection: 3mg/kg,ivgtt,D1, every 2 weeks for a treatment cycle. Bevacizumab Injection: 5mg/kg,ivgtt,D1, every 2 weeks for a treatment cycle.
Intervention: Sequential AG and mFOLFOX in Combination With Serplulimab Injection and Bevacizumab Injection
Outcomes
Primary Outcomes
Objective response rate(ORR)
Time Frame: [ up to 12 months]
The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%)
Secondary Outcomes
- Incidence of Treatment-Emergent 3/4 Adverse Events([up to 12 months after enrollment or study close])
- Progression-free survival (PFS)([ up to 12 months])
- Overall survival (OS)([ up to 36 months])
- Disease control rate (DCR)([ up to 12 months])