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

NCT04365049 | Unknown

• 1 other identifier: HepBilPan001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Adverse events

  two years

• Tumor response

  two years

Study Arms (2)

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.

Radiation: Radiotherapy; Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Camrelizumab

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).

Drug: Nab-paclitaxel; Drug: Gemcitabine

Interventions

Radiotherapy 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+Gemcitabine+Camrelizumab+Radiotherapy

Nab-paclitaxel DRUG

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

Nab-Paclitaxel+Gemcitabine; Nab-Paclitaxel+Gemcitabine+Camrelizumab+Radiotherapy

Gemcitabine DRUG

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

Nab-Paclitaxel+Gemcitabine; Nab-Paclitaxel+Gemcitabine+Camrelizumab+Radiotherapy

Camrelizumab 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+Camrelizumab+Radiotherapy

Eligibility Criteria

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

Study Population

Advanced Pancreatic Adenocarcinoma

You may qualify if:

• aged 18-75 years;
• histologically or cytologically proven diagnosis of pancreatic adenocarcinoma;
• treatment-naive locally advanced pancreatic cancer (locally advanced status was determined by our multidisciplinary team based on the National Comprehensive Cancer Network definitions);
• no distant metastasis as defined by CT or MRI of the chest, abdomen and pelvis;
• at least 1 measurable lesion based on the Response Evaluation Criteria in Solid Tumors criteria (RECIST) 1.1;
• an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
• adequate hematological, liver, renal function:
• absolute neutrophil count≥1500 cell/mm3;
• platelet count≥100×109/L;
• hemoglobin concentration \>90 g/L;
• albumin≥30 g/L ;
• total bilirubin\<1.5 times the upper limit of normal;
• alanine aminotransferase and aspartate aminotransferase≤3 times the upper limit of normal;
• serum creatinine concentration\<1.5 times the upper limit of the normal range or less and creatinine clearance rate≥45 mL/min;
• life expectancy of at least 3 months.

You may not qualify if:

• with any other malignancy within the 5 years before enrolment;
• 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;
• with peripheral sensory neuropathy at a grade \>1;
• with a history of allergy or hypersensitivity to the study drugs;
• pregnant or breast feeding women, reproductive aged women who refused to take adequate contraceptive measures during the study.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Frist Affliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Interventions

Radiotherapy; 130-nm albumin-bound paclitaxel; Gemcitabine; camrelizumab

Intervention Hierarchy (Ancestors)

Therapeutics; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Ming Kuang, PhD

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Central Study Contacts

Ming Kuang, PhD

CONTACT

008687755766; kuangm@mail.sysu.edu.cn

Zhenwei Peng, PhD

CONTACT

008687755766; pzhenw@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The vice president

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: April 1, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 22, 2023

Record last verified: 2023-02

Locations

CN (1)