PDAC - Pancreatic Ductal AdenocarcinomaNCT04365049
Nab-Paclitaxel and Gemcitabine Plus Camrelizumab and Radiotherapy for Locally Advanced Pancreatic Adenocarcinoma
An observational study of PDAC - Pancreatic Ductal Adenocarcinoma, run by Sun Yat-sen University at 1 site in China.
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) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- PDAC - Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Radiotherapy, Nab-paclitaxel and Gemcitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to Dec 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Advanced Pancreatic Adenocarcinoma
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Frist Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Ming Kuang, 008687755766 ext. 8576, kuangm@mail.sysu.edu.cn
About this study
Official title: Nab-Paclitaxel and Gemcitabine Plus Camrelizumab and Radiotherapy Versus Nab-Paclitaxel and Gemcitabine Alone for Locally Advanced Pancreatic Adenocarcinoma
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)
Read the 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
- Being tested
- Radiotherapy, Nab-paclitaxel, Gemcitabine, Camrelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
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-paclitaxelDrug
Eight 21-day cycles of nab-paclitaxel 125 mg/m² by intravenous infusion for approximately 30-45 mins on days 1 and 8.
GemcitabineDrug
Eight 21-day cycles of gemcitabine 1000mg/m² intravenous infusion for approximately 30 mins on days 1 and 8.
CamrelizumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: two years
Secondary outcomes (2)
Adverse events
adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).
Measured: two years
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.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 Apr 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PDAC - Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Kuang, Sun Yat-sen University
- Investigators
- Ming Kuang, PhD, Study chair, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365049
- Sponsor's protocol ID
- HepBilPan001
- Status last verified
- Feb 2023
- First submitted
- 24 Apr 2020
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nab-Paclitaxel and Gemcitabine Plus Camrelizumab and Radiotherapy Versus Nab-Paclitaxel and Gemcitabine Alone for Locally Advanced Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04365049
- Acronym / sponsor ID
- HepBilPan001
- Conditions
- PDAC - Pancreatic Ductal Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nab-Paclitaxel+Gemcitabine+Camrelizumab+Radiotherapy | – | Radiation: Radiotherapy, Drug: Nab-paclitaxel, Drug: Gemcitabine, Drug: CamrelizumabChemotherapy 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 | – | Drug: Nab-paclitaxel, Drug: GemcitabineChemotherapy 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced Pancreatic Adenocarcinoma
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyRadiotherapy 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. | Radiation | Nab-Paclitaxel+Gemcitabine+Camrelizumab+Radiotherapy |
| Nab-paclitaxelEight 21-day cycles of nab-paclitaxel 125 mg/m² by intravenous infusion for approximately 30-45 mins on days 1 and 8. | Drug | Nab-Paclitaxel+Gemcitabine, Nab-Paclitaxel+Gemcitabine+Camrelizumab+Radiotherapy |
| GemcitabineEight 21-day cycles of gemcitabine 1000mg/m² intravenous infusion for approximately 30 mins on days 1 and 8. | Drug | Nab-Paclitaxel+Gemcitabine, Nab-Paclitaxel+Gemcitabine+Camrelizumab+Radiotherapy |
| CamrelizumabAnti-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. | Drug | Nab-Paclitaxel+Gemcitabine+Camrelizumab+Radiotherapy |
Primary outcome
Progression-free survival
Time frame: 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
Time frame: 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.
2 secondary outcomes
Adverse events
Time frame: two years
Tumor response
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Kuang, PhD study chair
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PDAC - Pancreatic Ductal Adenocarcinoma, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Kuang, PhD (008687755766 ext. 8576, kuangm@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.