Efficacy and Safety of Camrelizumab Combined With Nab-Paclitaxel Plus Gemcitabine for Metastatic Pancreatic Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    117
  • sponsor
    Fudan University
Updated on 25 January 2021
paclitaxel
cancer
gemcitabine
gemcitabine injection

Summary

The present study is intended to investigate the objective response rate (ORR) and the progression-free survival (PFS) of the patients with histologically- or cytologically-confirmed metastatic pancreatic cancer after treating with the combination of camrelizumab, gemcitabine and nab-paclitaxel, and to investigate the overall survival (OS) and the adverse event (AE) of the patients with histologically- or cytologically-confirmed metastatic pancreatic cancer after treating with the combination of camrelizumab, gemcitabine and nab-paclitaxel.

Description

This a prospective, single-arm, open-label, phase 2 studye evaluating the efficacy and safety of camrelizumab, gemcitabine and nab-paclitaxel for metastatic pancreatic cancer patients. The primary endpoints are ORR and PFS, and the secondary are OS and adverse events.

Details
Condition Metastatic Pancreatic Cancer
Treatment nab paclitaxel, Gemcitabine Injection, Camrelizumab
Clinical Study IdentifierNCT04498689
SponsorFudan University
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

\. Signed informed consent form obtained prior to treatment. The patients were fully explained and understood the purpose, contents, predicted efficacy, pharmacological effects, and risks of this study. 2. target patients
the patients were histopathologically- or cytocologically-confirmed as metastatic pancreatic cancer
At least one measurable objective lesion (both primary and metastatic) was identified based on the RECIST 1.1 criteria
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
The expected survival after surgery 3 months
The subjects have good compliance, can be treated and followed up, and voluntarily comply with the relevant provisions of this study
No contraindications for camrelizumab, gemcitabine and nab-paclitaxel. 3. Age and reproductive status
Male and female patients at the age of 18-75
Subjects of child-bearing age must agree to take effective contraceptive measures during the study period; Serum or urine pregnancy tests must be negative for women of childbearing age 24 hours before the start of therapy
Women must not lactate

Exclusion Criteria

\. The target disease has cerebral metastasis; 2. Previously treated by anti-PD-1 or anti-PD-L1 drugs; 3. Received any investigational drug within 4 weeks before the first use of the research drug; 4. Enrolled in another clinical study, unless it is an observational (non-interventional) clinical study or an interventional follow-up clinical study; 5. medical history and complications
patients had uncontrolled serious medical condition that the investigator considered may affect the subject's to receive treatment under the study program. For example, patients with severe medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc
patients who are suffering active, known or suspected autoimmune diseases (including but limited to uveitis, enteritis, hepatitis, pituitary inflammation, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchodilator therapy, etc.). Subjects with hypothyroidism who only need hormone replacement therapy and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss) can be enrolled
Patients who are suffering from active tuberculosis infection: Patients with active pulmonary tuberculosis infection within 1 year before medication should be excluded even if they have been treated; patients with a history of active tuberculosis infection more than 1 year ago should also be excluded unless it is proven that they have received standard anti-TB treatment before
Patients who have previous interstitial lung disease or (non-infectious) pneumonia and requires oral or intravenous steroid therapy
Patients who need to receive long-term systemic hormones (dose equivalent to >10mg prednisone/day) or any other form of immunosuppressive therapy. Subjects using inhaled or topical corticosteroids can be enrolled
Patients who have uncontrolled heart disease, such as
New York Heart Association (NYHA) level 2 heart failure
Unstable angina
Myocardial infarction occurred within 1 year
Supraventricular or ventricular arrhythmias that have clinical significance and require treatment or intervention
Dementia, changing of mental state or any mental illness which could hinder understanding or informed consent or fill out questionnaires
History of allergy or hypersensitivity to any therapeutic ingredient
Combined with other malignant tumors excepted pancreatic cancer within the first 5 years of randomization, excepted well-treated basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical resection, and ductal carcinoma in situ of the breast after radical resection
Previously received systemic therapy for advanced/metastatic pancreatic cancer
Subjects who had previously been pathologically diagnosed with squamous cell carcinoma (no organ limitation) and received neoadjuvant/adjuvant therapy with taxa regimen
Patients who had Grade 2 or above Peripheral neuropathy according to CTCAE Ver. 5.0
Abnormal results of physical examination and laboratory examination
Absolute neutrophil count (ANC) 1.5109/L; Platelets (PLT) 80109/L; Hemoglobin (Hb) 90g/L
Aspartate aminotransferase (AST, or serum glutamic oxaloacetic transaminase, SGOT) and alanine aminotransferase (ALT, or serum glutamic pyruvate transaminase, SGPT) > 2.5 ULN (institutional upper limit of normal), > 5 ULN (hepatic metastases occasion); Total bilirubin (TBIL)>1.5 ULN
Creatinine (CRE)> 1.5 ULN
Prothrombin time (PT) and international normalized ratio (INR) > 1.5 ULN. Or activated partial thromboplastin time (aPTT) > 1.5 ULN. Unless the subject had received anticoagulant treatment
Subjects had hepatitis b surface antigen (HBsAg)-positive and HBV-DNA titer in peripheral blood greater than or equal to 1000 copy number /L; If HBsAg is positive and the HBV-DNA of peripheral blood 1000 copy number/L, the subjects will be eligible for inclusion if the investigator considers that chronic hepatitis b is stable and does not increase the risk of subjects
Human immunodeficiency virus (HIV)- or hepatitis C virus (HCV) positive patients
Patients who suffer from active infection requiring systemic treatment; 6. Patients need other concomitant anti-tumor drugs; 7. Participation in any trial drug treatment or another interventional clinical trial 30 days before screening period
Other conditions that the investigators considered are not suitable for the enrollment
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note