Non-Resectable Pancreas CarcinomaPhase 2NCT06393166
Sequential AG and mFOLFOX Combined With Serplulimab Injection and Bevacizumab Injection in Untreated Advanced Pancreatic Cancer
A Phase 2 study testing Sequential AG and mFOLFOX in Combination With Serplulimab Injection and Bevacizumab Injection in people with Non-Resectable Pancreas Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Resectable Pancreas Carcinoma
- What is being tested?
- Sequential AG and mFOLFOX in Combination With Serplulimab Injection and Bevacizumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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;
- a combination of other malignancies within the last 5 years, except cured squamous skin cancer, basal cell carcinoma, non-basal invasive bladder cancer, and prostate/cervical/breast cancer in situ;
- hepatic metastases comprising more than 50% of the total liver volume;
- uncontrolled comorbidities, including but not limited to the following
- Active HBV or HCV infection; (Note: HBV DNA and/or HCV RNA testing is required for subjects who are HBsAg positive and/or HCV antibody positive at Screening. Subjects who are negative for HBV DNA ≤500 IU/mL (or ≤2000 copies/mL) and/or HCV RNA are eligible for enrollment; HBsAg-positive subjects are required to have their HBV DNA monitored during the course of treatment);
- Known history of HIV infection or AIDS;
- Active syphilis;
- Active tuberculosis;
- Active or uncontrolled serious infection (≥ CTCAE grade 2 infection);
- Medication-uncontrolled hypertension (defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg;), symptomatic cardiac insufficiency (NYHA II-IV), unstable angina pectoris or myocardial infarction within 6 months, or the presence of a prolonged QTc or risk of torsades de pointes (baseline QTc>470 msec (women)/450 msec (men) < Fridericia method correction>, hypokalemia, long QT syndrome, atrial fibrillation with heart rate >100 bpm at rest or severe cardiac valvular disease, history of medically significant arrhythmias);
- unrecovered toxicity from prior antitumor therapy to CTCAE ≤ Grade 1 (NCI-CTCAE v5.0), except for baldness (any grade allowed) and peripheral neuropathy (recovery to ≤ Grade 2 required);
- history of prior allogeneic bone marrow or organ transplantation;
- prior history of allergic reaction, hypersensitivity reaction, intolerance to investigational drugs or similar medications; prior significant allergy to drugs or foods or other substances (e.g., severe allergic reaction, immune-mediated hepatotoxicity, immune-mediated thrombocytopenia, or anemia)
- pregnant and/or lactating women;
- other conditions that, in the opinion of the investigator, would affect the safety of or adherence to treatment with the study medication, including alcoholism, drug abuse, other serious illnesses (including psychiatric illnesses) that require comorbid treatment, the presence of serious laboratory test abnormalities, moderate to large amounts of plasmapheresis such as pleural fluid, pericardial effusion, ascites, and other concomitant familial or social factors, which would affect the safety of the patient;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Jieer Ying, 13858195803, hzyingjieer@163.com
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Non-Resectable Pancreas Carcinoma
- Being tested
- Sequential AG and mFOLFOX in Combination With Serplulimab Injection and Bevacizumab Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential AG and mFOLFOX in Combination With Serplulimab Injection and Bevacizumab InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sequential AG and mFOLFOX in Combination With Serplulimab Injection and Bevacizumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate(ORR)
The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%)
Measured: [ up to 12 months]
Secondary outcomes (4)
Progression-free survival (PFS)
Refers to the date from the date of admission to the date of the first progression of disease or death of any cause, using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Measured: [ up to 12 months]
Overall survival (OS)
The time interval between the start date of study drug and the date of death (any cause)
Measured: [ up to 36 months]
Disease control rate (DCR)
Percentage of confirmed cases including complete remission (CR), partial remission (PR) and disease stability (SD) among patients with evaluable efficacy
Measured: [ up to 12 months]
Incidence of Treatment-Emergent 3/4 Adverse Events
Number and percentage of participants with Adverse Events (any Grade and Grade 3/4)
Measured: [up to 12 months after enrollment or study close]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 May 2023
- Primary completion1 May 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Resectable Pancreas CarcinomaStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Jieer, Zhejiang Cancer Hospital
- Investigators
- Jieer Ying, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393166
- Sponsor's protocol ID
- IRB-2023-384
- Status last verified
- Apr 2024
- First submitted
- 28 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06393166
- Acronym / sponsor ID
- IRB-2023-384
- Conditions
- Non-Resectable Pancreas Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sequential AG and mFOLFOX in Combination With Serplulimab Injection and Bevacizumab Injection | Experimental | Drug: Sequential AG and mFOLFOX in Combination With Serplulimab Injection and Bevacizumab InjectionNab-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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (29 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sequential AG and mFOLFOX in Combination With Serplulimab Injection and Bevacizumab InjectionNab-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 |
Primary outcome
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 (%)
4 secondary outcomes
Progression-free survival (PFS)
Time frame: [ up to 12 months]
Overall survival (OS)
Time frame: [ up to 36 months]
Disease control rate (DCR)
Time frame: [ up to 12 months]
Incidence of Treatment-Emergent 3/4 Adverse Events
Time frame: [up to 12 months after enrollment or study close]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jieer Ying principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sequential AG and mFOLFOX in Combination With Serplulimab Injection and Bevacizumab Injection in people with Non-Resectable Pancreas Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jieer Ying (13858195803, jieerying@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate(ORR) (time frame: [ up to 12 months]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.