Recurrent Pancreatic CancerPhase 2NCT04902261
Tislelizumab Combined With Nab-paclitaxel and Gemcitabine for Recurrent Pancreatic Cancer
A Phase 2 study testing Tislelizumab, Nab paclitaxel and Gemcitabine in people with Recurrent Pancreatic Cancer, run by Changhai Hospital at 1 site in China.
Trial summary
To evaluate the efficacy of Tislelizumab combined with Nab-paclitaxel and Gemcitabine in the treatment of recurrent pancreatic cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Pancreatic Cancer
- What is being tested?
- Tislelizumab, Nab paclitaxel and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2020to 20 Nov 2023
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with radiologically or histologically confirmed postoperative Recurrent Pancreatic Cancer
- Patients with at least one measurable lesion (according to RECIST 1.1 criteria);
- Have not received gemcitabine-based regimen after surgery
- No systemic treatment after diagnosis of recurrence
- ECOG score 0-1
- Expected survival ≥ 3 months;
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- Liver function is essentially normal: absolute neutrophil count > 1500/mm ³; platelet count > 100,000/mm ³; creatinine less than 1.5 times the upper limit of normal or calculated creatinine clearance (CRCI) > 45 mL/min; total bilirubin ≤ 2.0 mg/dL; aspartate aminotransferase (AST) and alanine aminotransferase less than 2.5 times the upper limit of normal
- Appropriate to participate in this trial as assessed by the investigator before entering the study
- Male and female subjects of childbearing potential must agree to use an effective method of contraception throughout the study
- Signed Informed Consent Form
Who cannot join
- Patients who only undergo abdominal laparotomy but do not undergo resection of pancreatic tumor tissue
- Received gemcitabine-based regimen after surgery
- Systemic treatment after diagnosis of recurrence
- Patients with previous allergic reactions to similar drugs
- Pregnant or lactating patients
- Presence of pericardial effusion, uncontrolled pleural effusion, or clinically significant ascites at screening (including detectable ascites or ascites requiring puncture and aspiration on physical examination at screening)
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- History of interstitial lung disease, pneumonitis, or uncontrolled systemic disease, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc
- Patients with severe cardiovascular diseases within 12 months before enrollment, such as symptomatic coronary heart disease, ≥ grade II congestive heart failure, uncontrolled arrhythmia, myocardial infarction, etc
- Presence of any active immunodeficiency or autoimmune disease and/or history of any immunodeficiency or autoimmune disease that may recur at screening (e.g., hypothyroidism or hyperthyroidism, interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, etc)
- Use of steroids or other systemic immunosuppressive therapy 14 days prior to enrollment
- Patients with other previous malignancies who are not cured
- Immunodeficient patients, such as HIV-positive
- Uncontrollable psychosis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, 200433
Shiwei Guo, Doctor, +8618621500666, gestwa@163.com
Gang Jin, Doctor
About this study
Official title: Prospective Exploratory Study of Tislelizumab Combined With Nab-paclitaxel and Gemcitabine for Postoperative Recurrence of Pancreatic Cancer
To evaluate the efficacy of Tislelizumab combined with Nab-paclitaxel and Gemcitabine in the treatment of recurrent pancreatic cancer
Read the detailed description
There is heterogeneity in desmoplasia between different metastatic sites in pancreatic cancer. The tumor quasi-characteristics of patients with metastatic PDAC at presentation were more obvious than those of epithelial characteristics, and the quasi-and epithelial subtypes showed different responses to chemotherapy regimens, and the epithelial phenotype tumor quasi-phenotype was associated with metastasis-free survival. Therefore, different metastases of pancreatic cancer may respond differently to medical treatment. There were different metastases after postoperative recurrence of pancreatic cancer, 25.2% had only liver metastases, 14.7% had only lung metastases, 14.7% had multiple distant metastases, and about more than half of the patients had postoperative recurrence with only distant metastases and no in situ metastasis. Then whether there is a difference in the efficacy of PD1 drug therapy in patients with different metastases needs to be further verified.
- Conditions
- Recurrent Pancreatic Cancer
- Being tested
- Tislelizumab, Nab paclitaxel, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Tislelizumab 200 mg every three weeks
Nab paclitaxelDrug
Nab-paclitaxel 125mg/m2 on d1 and d8 every three weeks
GemcitabineDrug
Gemcitabine 1000mg/m2 on d1 and d8 every three weeks
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab combined with Nab-paclitaxel and Gemcitabine | Experimental | Not described Receives: Drug: Tislelizumab; Drug: Nab paclitaxel; Drug: Gemcitabine |
| Nab-paclitaxel and Gemcitabine | Active comparator | Not described Receives: Drug: Nab paclitaxel; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Year Survival Rates
The proportion of patients who survive more than 1 year after treatment.
Measured: Up to 2 years
Secondary outcomes (4)
Overall Response Rate（ORR)
the proportion of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR)
Measured: Up to 2 years
Progression Free Survival (PFS)
The time from the date of treatment to the first of either disease progression, relapse or death
Measured: Up to 2 years
Overall survival (OS)
The time from the date of treatment start to the date of death or to the date of last follow-up for patients alive
Measured: Up to 2 years
Adverse Events (AEs)
the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0; Surgical safety including Intraoperative blood loss，PHLF assessed by ISGLS（2012），Postoperative complications evaluated by modified Clavien-Dindo system.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start20 Nov 2020
- Primary completion20 Nov 2023 (estimated)
- Study completion20 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo ShiWei, Changhai Hospital
- Investigators
- Gang Jin, Doctor, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902261
- Sponsor's protocol ID
- CHEC2020-144
- Status last verified
- Aug 2023
- First submitted
- 20 May 2021
- Last updated
- 1 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Exploratory Study of Tislelizumab Combined With Nab-paclitaxel and Gemcitabine for Postoperative Recurrence of Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04902261
- Acronym / sponsor ID
- CHEC2020-144
- Conditions
- Recurrent Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 20 Nov 2023 (estimated)
- Study completion
- 20 Nov 2023 (estimated)
- First posted
- 26 May 2021 (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.
To evaluate the efficacy of Tislelizumab combined with Nab-paclitaxel and Gemcitabine in the treatment of recurrent pancreatic cancer
Detailed description
There is heterogeneity in desmoplasia between different metastatic sites in pancreatic cancer. The tumor quasi-characteristics of patients with metastatic PDAC at presentation were more obvious than those of epithelial characteristics, and the quasi-and epithelial subtypes showed different responses to chemotherapy regimens, and the epithelial phenotype tumor quasi-phenotype was associated with metastasis-free survival. Therefore, different metastases of pancreatic cancer may respond differently to medical treatment. There were different metastases after postoperative recurrence of pancreatic cancer, 25.2% had only liver metastases, 14.7% had only lung metastases, 14.7% had multiple distant metastases, and about more than half of the patients had postoperative recurrence with only distant metastases and no in situ metastasis. Then whether there is a difference in the efficacy of PD1 drug therapy in patients with different metastases needs to be further verified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab combined with Nab-paclitaxel and Gemcitabine | Experimental | Drug: Tislelizumab, Drug: Nab paclitaxel, Drug: Gemcitabine |
| Nab-paclitaxel and Gemcitabine | Active comparator | Drug: Nab paclitaxel, Drug: Gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with radiologically or histologically confirmed postoperative Recurrent Pancreatic Cancer
- Patients with at least one measurable lesion (according to RECIST 1.1 criteria);
- Have not received gemcitabine-based regimen after surgery
- No systemic treatment after diagnosis of recurrence
- ECOG score 0-1
Key exclusion criteria (13 listed)
- Patients who only undergo abdominal laparotomy but do not undergo resection of pancreatic tumor tissue
- Received gemcitabine-based regimen after surgery
- Systemic treatment after diagnosis of recurrence
- Patients with previous allergic reactions to similar drugs
- Pregnant or lactating patients
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 |
|---|---|---|
| TislelizumabTislelizumab 200 mg every three weeks | Drug | Tislelizumab combined with Nab-paclitaxel and Gemcitabine |
| Nab paclitaxelNab-paclitaxel 125mg/m2 on d1 and d8 every three weeks | Drug | Nab-paclitaxel and Gemcitabine, Tislelizumab combined with Nab-paclitaxel and Gemcitabine |
| GemcitabineGemcitabine 1000mg/m2 on d1 and d8 every three weeks | Drug | Nab-paclitaxel and Gemcitabine, Tislelizumab combined with Nab-paclitaxel and Gemcitabine |
Primary outcome
1-Year Survival Rates
Time frame: Up to 2 years
The proportion of patients who survive more than 1 year after treatment.
4 secondary outcomes
Overall Response Rate（ORR)
Time frame: Up to 2 years
Progression Free Survival (PFS)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
Adverse Events (AEs)
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Gang Jin, Doctor principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab, Nab paclitaxel and Gemcitabine in people with Recurrent Pancreatic Cancer, run by Changhai Hospital 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 10 inclusion and 13 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 1 Sep 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shiwei Guo, Doctor (+8618621500666, gestwa@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Year Survival Rates (time frame: Up to 2 years). 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 1 Sep 2023.