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

NCT04498689 | Unknown Phase 2

• 1 other identifier: CSPAC-27
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Pancreatic Cancer

Keywords

Metastatic pancreatic cancer; Pancreatic Adenocarcinoma; Camrelizumab; Nab-paclitaxel; Gemcitabine

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate

  To evaluate the Overall Response Rate of patients with metastatic pancreatic cancer after the treatment of camrelizumab with nab-paclitaxel plus gemcitabine.

  from enrollment to time of evaluation or date of death from any cause, whichever came first, estimated 18 months

• Progression Free Survival

  To evaluate the Progression Free Survival of patients with metastatic pancreatic cancer after the treatment of camrelizumab with nab-paclitaxel plus gemcitabine.

  from enrollment to time of evaluation or date of death from any cause, whichever came first, estimated 18 months

Secondary Outcomes (2)

• overall survival

  from enrollment to time of evaluation or date of death from any cause, whichever came first, estimated 18 months

• adverse events

  from enrollment to time of evaluation or date of death from any cause, whichever came first, estimated 18 months

Study Arms (1)

camrelizumab + nab-paclitaxel + gemcitabine

EXPERIMENTAL

PD-1 Monoclonal Antibody Camrelizumab at 200 mg on Day 1 and 15 nab-paclitaxel at 100 mg/m2 on Day 1, 8, and 15; gemcitabine at 1000 mg/m2 on Day 1, 8, and 15

Drug: Camrelizumab; Drug: Nab paclitaxel; Drug: Gemcitabine Injection

Interventions

Camrelizumab DRUG

Patients firstly receive camrelizumab 200 mg per time (iv, no less than 20 minutes and no more than 60 minutes, rinse time included) on Day 1 and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence, unacceptable toxicity, death or begin a novel therapeutic.

camrelizumab + nab-paclitaxel + gemcitabine

Nab paclitaxel DRUG

Patients secondly receive nab-paclitaxel 100 mg/m2 (iv, at least 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence, unacceptable toxicity, death or begin a novel therapeutic.

Also known as: Albumin paclitaxl

camrelizumab + nab-paclitaxel + gemcitabine

Gemcitabine Injection DRUG

At last, patients receive gemcitabine 1000 mg/m2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence, unacceptable toxicity, death or begin a novel therapeutic.

Also known as: Gemcitabine

camrelizumab + nab-paclitaxel + gemcitabine

Eligibility Criteria

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

You may qualify if:

• \. 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.
• \. 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
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• 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.

You may not qualify if:

• \. 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;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

camrelizumab; Taxes; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Xian-Jun Yu

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xian-Jun Yu

CONTACT

+86 21 64175590; wangwenquan@fudanpci.org

Wen-Quan Wang

CONTACT

wangwenquan@fudanpci.org

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: Vice President

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: August 4, 2020
• Study Start: August 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 4, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)