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

Recruiting

• Conditions: PDAC - Pancreatic Ductal Adenocarcinoma
• Interventions: Radiation: Radiotherapy; Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Camrelizumab

• Registration Number: NCT04365049
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-04-24
• Study First Posted: 2020-04-28
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-20
• Last Update Posted: 2023-02-22
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nab-Paclitaxel+Gemcitabine+Camrelizumab+Radiotherapy	Nab-paclitaxel	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.
Nab-Paclitaxel+Gemcitabine+Camrelizumab+Radiotherapy	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.
Nab-Paclitaxel+Gemcitabine	Nab-paclitaxel	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+Gemcitabine+Camrelizumab+Radiotherapy	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). 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.
Nab-Paclitaxel+Gemcitabine+Camrelizumab+Radiotherapy	Camrelizumab	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.
Nab-Paclitaxel+Gemcitabine	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).

Primary Outcome Measures

Name	Time	Method
Progression-free survival	two years	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.
Overall survival	two years	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.

Secondary Outcome Measures

Name	Time	Method
Adverse events	two years	adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).
Tumor response	two years	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.

Trial Locations

Locations (1)

Frist Affliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China