Sequential AG and mFOLFOX Combined With Serplulimab Injection and Bevacizumab Injection in Untreated Advanced Pancreatic Cancer

NCT06393166 | Recruiting Phase 2

• 1 other identifier: IRB-2023-384
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Resectable Pancreas Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate(ORR)

  The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%)

  [ up to 12 months]

Secondary Outcomes (4)

• Progression-free survival (PFS)

  [ up to 12 months]

• Overall survival (OS)

  [ up to 36 months]

• Disease control rate (DCR)

  [ up to 12 months]

• Incidence of Treatment-Emergent 3/4 Adverse Events

  [up to 12 months after enrollment or study close]

Other Outcomes (1)

• Blood or tissue biomarkers

  [up to 12 months after enrollment or study close]

Study Arms (1)

Sequential AG and mFOLFOX in Combination With Serplulimab Injection and Bevacizumab Injection

EXPERIMENTAL

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.

Drug: Sequential AG and mFOLFOX in Combination With Serplulimab Injection and Bevacizumab Injection

Interventions

Sequential AG and mFOLFOX in Combination With Serplulimab Injection and Bevacizumab Injection DRUG

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.

Sequential AG and mFOLFOX in Combination With Serplulimab Injection and Bevacizumab Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• liver function: (no albumin infusion within 14 days prior to screening): Serum total bilirubin ≤ 1.5 x ULN (with biliary obstruction, allowing enrollment of subjects undergoing biliary drainage or in the midst of stenting therapy who have a total bilirubin ≤ 2.5 x ULN). In subjects without liver metastasis, Aspartate aminotransferase (AST), alanine aminotransferase (ALT)≤2.5×ULN; In subjects with liver metastasis, ALT and AST≤5×ULN, but without elevated bilirubin;
• Renal function: serum creatinine ≤1.5 x ULN, creatinine clearance (CCr) ≥50 mL/min, urinary protein \<2+ (if urinary protein ≥2+, 24-hour (h) urinary protein quantification can be carried out, and 24h urinary protein quantification \<1.0 g can be enrolled)
• Heart function: New York College of Cardiology (NYHA) rating \< 3; Left ventricular ejection fraction ≥50%;
• Male or female patients of childbearing potential will voluntarily use an effective method of contraception, such as a double-barrier contraceptive method, condoms, oral or injectable contraceptives, and an intrauterine device (IUD), for the duration of the study and up to 6 months after the last study dose. All female patients will be considered of childbearing potential unless the female patient is naturally menopausal, artificially menopausal or sterilized;
• Subject's ability and willingness to comply with visits, treatment plans, laboratory tests, and other study-related processes as specified in the study protocol.

You may not qualify if:

• 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
• a 10% or greater weight loss in comparison to the weight loss at the time of ICF signing within 72 hours prior to enrollment in this study; and
• within 72 hours prior to study entry, the subject's ECOG physical status score increases by ≥1 point compared to the ICF score; 13. within 28 hours prior to study entry, the subject's ECOG physical status score increases by ≥1 point compared to the ICF score; and
• has received a live vaccine (including live attenuated vaccine) within 28 days prior to enrollment in this study;
• previous or current interstitial pneumonia/pneumatosis, unless determined by the investigator to be inactive and not requiring hormonal therapy; and
• pre-existing or current autoimmune disease, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, tuberculosis, Wegener's syndrome (granulomatous disease with polyangiitis), Graves' disease, rheumatoid arthritis, hypopituitarism, uveitis, autoimmune hepatitis, systemic sclerosis ( Scleroderma, etc.), Hashimoto's thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain-Barre syndrome). The following conditions are excluded: type I diabetes mellitus, hypothyroidism stabilized by hormone replacement therapy (including hypothyroidism caused by autoimmune thyroid disease), psoriasis or vitiligo that does not require systemic therapy;

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jieer Ying

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jieer Ying

CONTACT

13858195803; jieerying@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: May 1, 2024
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: December 31, 2025
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)