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Pancreatic Adenocarcinoma MetastaticPhase 1/2NCT03633734

Efficacy Evaluation of Sequential Treatment With AG and Modified Folfirinox in Metastatic Pancreatic Adenocarcinoma

A Phase 1/2 study testing Sequential Treatment in people with Pancreatic Adenocarcinoma Metastatic and Chemotherapy Effect, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The prognosis of pancreatic cancer is extremely poor. Current guidelines recommend Nab-paclitaxel, Gemcitabine and modified Folfirinox as the first-line chemotherapeutic regimen. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Sequential Treatment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteChina
Study dates
1 Jul 2018to 31 Dec 2024
Phase
Phase 1/2
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically diagnosed metastatic pancreatic adenocarcinoma (excluding islet cell tumor) that can be measured according to RECIST criteria.
  • Without Radiotherapy, surgery, chemotherapy or experimental treatment for metastatic pancreatic cancer. Previous use of 5-FU or gemcitabine as a radiosensitizer in adjuvant therapy is allowed, but it should be taken at least 6 months ago and no residual toxicity. Patients receiving cytotoxic doses of gemcitabine or any other chemotherapy in adjuvant therapy are not eligible for this study.
  • ECOG score 0-1 points.
  • The first diagnosis time of metastatic pancreatic cancer should be within 6 weeks of the initial of treatment. Note: This interval is calculated from the date of final assessment of the confirmed pancreatic cancer metastasis.
  • No jaundice symptoms before treatment. Pain should be stable, and no need to adjust analgesic treatment. Patients with obvious or symptomatic ascites should be drained before treatment.
  • With enough blood cell counts during the screening period(less than 14 days before the treatment): 1) The absolute count of neutrophils(ANC) is more than 1.5 ×10^9/L; 2) Platelet count was greater than 100,000/mm^3 (100 x10^9/L); 3).
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  • Hemoglobin (Hgb) is more than 9 g/dL.
  • With normal blood biochemical parameters during the screening period(less than 14 days before the treatment): 1). AST (SGOT), ALT (SGPT) <2.5*ULN, if there is obvious liver metastasis, it is allowed to <5*ULN. 2). Total bilirubin is less than ULN. 3). Serum creatinine is within the normal limit, or the serum creatinine level is higher or lower than the normal value of the body, but the calculated clearance rate is more than 60 mL/min/1.73 m^2. If creatinine clearance is used, the actual body weight should be used to calculate creatinine clearance (for example, the Cockroft-Gault formula). Patients with body mass index (BMI) >30 kg/m^2 should use fat free body weight.
  • Acceptable coagulation test results (less than 14 days before treatment): prothrombin time (PT) and partial thromboplastin time (PPT) were within the normal limit (+15%).
  • With no clinically significant abnormal urine analysis (less than 14 days before treatment).
  • Male or non pregnant and non lactating women aged 18 or above who signed the informed consent.
  • Patients were informed of the nature of the study and agreed to participate in the study, and informed consent was signed before participating in any research-related activities.

Who cannot join

  • With brain metastases.
  • Only locally progressive diseases.
  • Serum albumin level decreased by more than 20% within 72 hours of first days before screening visit to first cycle.
  • With a history of malignancies (including chronic leukemia) over the past 5 years. Patients with previous history of carcinoma in situ or basal cell or squamous cell carcinoma can be included. Patients with other malignancies who have been cured by surgery or surgery plus radiotherapy alone and remain disease-free for at least five years are also eligible.
  • Suffering from active or uncontrollable bacterial, viral or fungal infections requiring systemic treatment.
  • Known HIV infection, and/or active hepatitis B virus or hepatitis C virus infection (for patients with history of HBV or HCV infection, should be discussed with researchers).
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  • Major surgeries were performed within 4 weeks of the first day of treatment in this study (i.e. non-removal of organs for diagnostic biopsy).
  • Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, New York Heart Association (NYHA) grade III-IV heart failure, uncontrolled hypertension, clinically significant arrhythmias or electrocardiographic (ECG) abnormalities, cerebrovascular accidents, transient ischemic attacks, epileptic seizures or clinically significant arrhythmia or abnormal electrocardiogram (ECG) history within 6 months before treatment.
  • With history of allergy or hypersensitivity of any research drug or its adjunct.The patient presents the events outlined in the "Contraindications or Special Warnings and Cautions" section of the product or control drug prescription information.
  • With history of connective tissue diseases (such as lupus, scleroderma, nodular arteritis).
  • With history of interstitial pneumonia, slow progressive dyspnea, dry cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, allergic pneumonia, or multiple allergies.
  • Any condition that may impair patient safety or integrity of research data, including serious medical risk factors, medical events, laboratory abnormalities, or mental illness.
  • Patients entering any other clinical study, testing for an intervention drug, or may interfere with the evaluation of this study procedure.
  • Patients are unwilling or unable to follow the research procedure or plan to take 7 or more consecutive days off during the study period.

Trial locations and contacts

1 site in 1 country.

Tingbo Liang, MD PhD contact

8613666676128

liangtingbo@zju.edu.cn

Qi Zhang, MD contact

8613819137113

zhangqi86@gmail.com

China1 site, 1 recruiting

  • The second affiliated hospital of Zhejiang University

    Hangzhou, Zhejiang, 310009

    Qi Zhang, MD, 8613819137113

    Recruiting

Other trials in China

About this study

Official title: Efficacy Evaluation of Sequential Treatment With Nab-paclitaxel Plus Gemcitabine and Modified Folfirinox in Metastatic Pancreatic Adenocarcinoma

The prognosis of pancreatic cancer is extremely poor. Current guidelines recommend Nab-paclitaxel, Gemcitabine and modified Folfirinox as the first-line chemotherapeutic regimen. Studies have shown that sequential chemotherapeutic regimen can effectively delay the drug resistance and improve the effect of chemotherapy. Here investigators intend to assess the effect of sequential treatment with Nab-paclitaxel plus Gemcitabine and modified Folfirinox on metastatic pancreatic adenocarcinoma.

Read the detailed description

Investigators chose metastatic pancreatic adenocarcinoma patients who can't meet surgical criteria. The planned treatment was given to the participants after enrollment. Objective remission rate, disease control rate, tumor size, progression-free survival, overall survival, drugs related side effects and other endpoints events were recorded and analyzed, to assess the sequential treatment with Nab-paclitaxel plus Gemcitabine and modified Folfirinox could or couldn't effectively control the progress of metastatic pancreatic adenocarcinoma.

Being tested
Sequential Treatment
Keywords
Pancreatic cancer, Pancreatic Adenocarcinoma, Gemcitabine, Nab-paclitaxel, Modified Folfirinox, Sequential treatment
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sequential TreatmentDrug

    Also called Sequential Treatment With AG and Modified Folfirinox

    One cycle of the treatment lasts for 56 days. Patients will receive chemotherapy based on Nab-paclitaxel Plus Gemcitabine and modified Folfirinox in sequence order. The cycle will repeat until progression or intolerance of toxicity.

Study groups in NCT03633734
Study groupRoleWhat they receive
Sequential treatmentExperimentalOne cycle of sequential treatment lasts for 56 days. 1. Stage 1(28 days): AG regimen. Nab-paclitaxel (Abraxane) 125mg/m^2 + gemcitabine 1000mg/m^2 (days 1, 8, 15, 28) 2. Stage 2(28 days)：mFolfirinox regimen. Fluorouracil 2400 mg/m^2 continuous intravenous drip 46h + calcium folinate 400 mg/m^2 + irinotecan 135 mg/m^2 + oxaliplatin 68 mg/m^2 (day 1, 15, a total of 28 days). Repeat the cycle above until progression or intolerance of toxicity.
Receives: Drug: Sequential Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    The time of initial response until documented tumor progression.

    Measured: Up to approximately 60 months

Secondary outcomes (6)

  1. Overall survival

    The time of initial response until documented patient death.

    Measured: Up to approximately 60 months

  2. Objective response rate

    Percentage of people does not get worse for a period of time after diagnosis

    Measured: Up to approximately 60 months

  3. Disease control rate

    Percentage of patients whose cancer doesn't progress after treatment

    Measured: Up to approximately 60 months

  4. Carbohydrate antigen 19-9

    Serum Carbohydrate antigen 19-9 level

    Measured: Up to approximately 60 months

  5. EORTC QLQ - PAN26

    Assessed by the European Organization for Research and Treatment of Cancer Quality of Life-pancreatic cancer 26 score(EORTC QLQ - PAN26)

    Measured: Up to approximately 60 months

  6. Common Toxicity Criteria for Adverse Effects

    According to Common Toxicity Criteria for Adverse Effects version 4

    Measured: Up to approximately 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2018
  2. Study start1 Jul 2018
  3. Primary completion31 Aug 2023 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03633734
Sponsor's protocol ID
SAHZJU-Y2018-058
Status last verified
Aug 2018
First submitted
14 Aug 2018
Last updated
22 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Sequential Treatment in people with Pancreatic Adenocarcinoma Metastatic and Chemotherapy Effect, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 12 inclusion and 14 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 22 Aug 2018. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Tingbo Liang, MD PhD (8613666676128, liangtingbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: Up to approximately 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03633734.

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 22 Aug 2018.

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