Loading clinical trials...

Efficacy and Safety of Camrelizumab Combined With Nab-Paclitaxel Plus Gemcitabine for Metastatic Pancreatic Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of PD-1 Antibody Camrelizumab in Combination With Nab-paclitaxel Plus Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer

NCT04498689•Fudan University

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. 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
•1. the patients were histopathologically- or cytocologically-confirmed as metastatic pancreatic cancer.
•2. At least one measurable objective lesion (both primary and metastatic) was identified based on the RECIST 1.1 criteria;
•3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
•4. The expected survival after surgery ≥ 3 months
•5. The subjects have good compliance, can be treated and followed up, and voluntarily comply with the relevant provisions of this study
•6. No contraindications for camrelizumab, gemcitabine and nab-paclitaxel. 3. Age and reproductive status
•
•1. Male and female patients at the age of 18-75
+2 more criteria

Exclusion Criteria

•1\. 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
•1. 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.
•2. 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;
•3. 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;
•4. Patients who have previous interstitial lung disease or (non-infectious) pneumonia and requires oral or intravenous steroid therapy;
•5. 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;
•6. Patients who have uncontrolled heart disease, such as:
•1. New York Heart Association (NYHA) level 2 heart failure;
•2. Unstable angina;
•3. Myocardial infarction occurred within 1 year
+15 more criteria

Locations (1)

Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

August 1, 2019

Primary Completion Date

December 31, 2022

Completion Date

December 31, 2022

Last Updated

August 4, 2020

Enrollment

117

ESTIMATED participants

Conditions

Metastatic Pancreatic Cancer

Interventions

Camrelizumab

DRUG

Nab paclitaxel

DRUG

Gemcitabine Injection

DRUG

Contacts

Xian-Jun Yu

CONTACT

+86 21 64175590 wangwenquan@fudanpci.org

Wen-Quan Wang

CONTACT

wangwenquan@fudanpci.org

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

NCT07409272

Pancreatic CancerMetastatic Pancreatic Cancer+1 more

View study

RECRUITINGPHASE2

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

NCT05065801

Metastatic Pancreatic Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 4, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC

Nal-IRI/5-FU/LV Chemotherapy Combined With PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT as Second-line Therapy in Metastatic Pancreatic Cancer Patients

A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer

Irinotecan Hydrochloride Liposome Injection (II)in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Metastatic Pancreatic Cancer