Nab-Paclitaxel and Gemcitabine Plus Camrelizumab and Radiotherapy for Locally Advanced Pancreatic Adenocarcinoma

PDAC - Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

Nab-Paclitaxel and Gemcitabine Plus Camrelizumab and Radiotherapy Versus Nab-Paclitaxel and Gemcitabine Alone for Locally Advanced Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04365049
• Other study ID #: HepBilPan001
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: Sun Yat-sen University
• Contact: Ming Kuang, PhD
• Phone: 008687755766
• Email: kuangm[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The study is a prospective and observational cohort study. The purpose is to to investigate the safety and efficacy of nab-paclitaxel and gemcitabine plus camrelizumab and radiotherapy versus nab-paclitaxel and gemcitabine alone for locally advanced pancreatic adenocarcinoma (PDAC)

Description:

We will prospectively collect 100 patients who receive nab-paclitaxel and gemcitabine plus camrelizumab and radiotherapy or nab-paclitaxel and gemcitabine alone. Data will be stored in a private database. The process of data collection will be supervised and regular data examination will be performed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. aged 18-75 years;

2. histologically or cytologically proven diagnosis of pancreatic adenocarcinoma;

3. treatment-naive locally advanced pancreatic cancer (locally advanced status was determined by our multidisciplinary team based on the National Comprehensive Cancer Network definitions);

4. no distant metastasis as defined by CT or MRI of the chest, abdomen and pelvis;

5. at least 1 measurable lesion based on the Response Evaluation Criteria in Solid Tumors criteria (RECIST) 1.1;

6. an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;

7. adequate hematological, liver, renal function:

1. absolute neutrophil count=1500 cell/mm3;

2. platelet count=100×109/L;

3. hemoglobin concentration >90 g/L;

4. albumin=30 g/L ;

5. total bilirubin<1.5 times the upper limit of normal;

6. alanine aminotransferase and aspartate aminotransferase=3 times the upper limit of normal;

7. serum creatinine concentration<1.5 times the upper limit of the normal range or less and creatinine clearance rate=45 mL/min;

8. life expectancy of at least 3 months.

Exclusion Criteria:

1. with any other malignancy within the 5 years before enrolment;

2. with active infections (bacterial, viral, or fungal) requiring systematic treatment, with hepatitis B or C infection, or a history of HIV infection, or receiving immunosuppressive therapy;

3. with peripheral sensory neuropathy at a grade >1;

4. with a history of allergy or hypersensitivity to the study drugs;

5. pregnant or breast feeding women, reproductive aged women who refused to take adequate contraceptive measures during the study.

Related Conditions & MeSH terms

• Adenocarcinoma
• PDAC - Pancreatic Ductal Adenocarcinoma

Intervention

Radiation:
• Radiotherapy
Radiotherapy started after two cycles of chemotherapy. External beam radiation therapy was performed using an intensity modulated radiation therapy technique. The gross target volume included the gross primary tumor and positive regional lymph nodes as defined by the multiphasic imaging. A total radiation dose greater than 50 Gy without damaging organ function was the essential requirement.

Drug:
• Nab-paclitaxel
Eight 21-day cycles of nab-paclitaxel 125 mg/m² by intravenous infusion for approximately 30-45 mins on days 1 and 8.
• Gemcitabine
Eight 21-day cycles of gemcitabine 1000mg/m² intravenous infusion for approximately 30 mins on days 1 and 8.
• Camrelizumab
Anti-PD-1 antibody (camrelizumab, Hengrui Medicine Co., Ltd) 200 mg was administered intravenously for 30 mins every three weeks. During the chemotherapy-treated period, camrelizumab was administered on day 1 of each 21-day cycle before the infusion of chemotherapy.

Locations

Country	Name	City	State
China	Frist Affliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	defined as the time from randomization until disease progression or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive.	two years
Primary	Overall survival	defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.	two years
Secondary	Adverse events	adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).	two years
Secondary	Tumor response	measured according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 by means of computed tomography (CT) or magnetic resonance imaging (MRI) at each follow-up.	two years