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

NCT ID: NCT04365049

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2023-12-31

Brief 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)

Detailed 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.

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Nab-Paclitaxel+Gemcitabine+Camrelizumab+Radiotherapy

Chemotherapy consisted of eight 21-day cycles of nab-paclitaxel plus gemcitabine (nab-paclitaxel 125 mg/m² by intravenous infusion for approximately 30-45 mins, followed by gemcitabine 1000mg/m² intravenous infusion for approximately 30 mins on days 1 and 8). 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. Radiotherapy started after two cycles of chemotherapy. A total radiation dose greater than 50 Gy without damaging organ function was the essential requirement.

Radiotherapy

Intervention Type: RADIATION

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.

Nab-paclitaxel

Intervention Type: DRUG

Eight 21-day cycles of nab-paclitaxel 125 mg/m² by intravenous infusion for approximately 30-45 mins on days 1 and 8.

Gemcitabine

Intervention Type: DRUG

Eight 21-day cycles of gemcitabine 1000mg/m² intravenous infusion for approximately 30 mins on days 1 and 8.

Camrelizumab

Intervention Type: DRUG

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.

Nab-Paclitaxel+Gemcitabine

Chemotherapy consisted of eight 21-day cycles of nab-paclitaxel plus gemcitabine (nab-paclitaxel 125 mg/m² by intravenous infusion for approximately 30-45 mins, followed by gemcitabine 1000mg/m² intravenous infusion for approximately 30 mins on days 1 and 8).

Nab-paclitaxel

Intervention Type: DRUG

Eight 21-day cycles of nab-paclitaxel 125 mg/m² by intravenous infusion for approximately 30-45 mins on days 1 and 8.

Gemcitabine

Intervention Type: DRUG

Eight 21-day cycles of gemcitabine 1000mg/m² intravenous infusion for approximately 30 mins on days 1 and 8.

Interventions

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.

Intervention Type: RADIATION

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.

Intervention Type: DRUG

Gemcitabine

Eight 21-day cycles of gemcitabine 1000mg/m² intravenous infusion for approximately 30 mins on days 1 and 8.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Ming Kuang

The vice president

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Kuang, PhD

Role: STUDY_CHAIR

First Affiliated Hospital, Sun Yat-Sen University

Locations

Frist Affliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ming Kuang, PhD

Role: CONTACT

kuangm@mail.sysu.edu.cn

008687755766 ext. 8576

Zhenwei Peng, PhD

Role: CONTACT

pzhenw@mail.sysu.edu.cn

008687755766 ext. 8576

Facility Contacts

Ming Kuang

Role: primary

kuangm@mail.sysu.edu.cn

008687755766 ext. 8576

Other Identifiers

HepBilPan001

Identifier Type: -

Identifier Source: org_study_id