Advanced Pancreatic CancerPhase 2NCT05298020
Envafolimab Combined With Endostar and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer
A Phase 2 study testing Envafolimab, Endostar and Nab paclitaxel in people with Advanced Pancreatic Cancer, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial summary
This is a single-arm, open-label, exploratory study to evaluate efficacy and safety of envafolimab combined with endostar and nab-paclitaxel plus gemcitabine for first-line treatment of advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Pancreatic Cancer
- What is being tested?
- Envafolimab, Endostar and Nab paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 1 Apr 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
- Pathologically proven pancreatic cancer ;
- Age ≥ 18 years old, gender is not limited ; Expected survival ≥ 3 months ; ECOG 0-1; At least one measurable objective tumor lesion by spiral CT examination, the maximum diameter ≥ 1cm(according to RECIST 1.1); No previous chemotherapy, radiotherapy, immunotherapy, targeted therapy; The function of major organs is good, that is, the relevant inspection indicators within 14 days before enrollment meet the following requirements:(Hemoglobin ≥ 90 g/L (no blood transfusion within 14 days);Neutrophil count > 1.5×109/L; Platelet count ≥ 100×109/L;Total bilirubin ≤ 1.5×ULN (upper limit of normal);Blood alanine aminotransferase (ALT) or blood aspartate aminotransferase (AST) ≤2.5×ULN; if liver metastases, ALT or AST ≤ 5×ULN;Endogenous creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula);Cardiac Doppler Ultrasound Assessment: Left Ventricular Ejection Fraction (LVEF) ≥ 50% );
Who cannot join
- Patients with other malignant tumors in the past or at the same time, and those tumors that are judged by the investigator to not affect the patient's life in the short term can be excluded; Participated in clinical trials of other drugs within four weeks ; Patients with known CNS metastases or a history of CNS metastases prior to screening. For patients with clinically suspected central nervous system metastasis, CT or MRI examination must be performed within 28 days before enrollment to exclude central nervous system metastasis; Patients with a history of unstable angina pectoris; newly diagnosed angina pectoris within 3 months before screening or myocardial infarction events within 6 months before screening; arrhythmia (including QTcF: male ≥ 450 ms, female ≥ 470 ms) requires Long-term use of antiarrhythmic drugs and New York Heart Association class ≥ II cardiac insufficiency; Urine routine indicates urine protein ≥++ and confirmed 24-hour urine protein quantification >1.0 g; For female subjects: should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study treatment period; Serum or urine pregnancy test must be negative within 7 days and must be non-nursing. Male subjects: should be surgically sterilized, or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study treatment period; Have used immune targeted therapy drugs; Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; Infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other patients who need corticosteroids; History of chronic autoimmune diseases, such as systemic lupus erythematosus; history of inflammatory bowel disease such as ulcerative colitis, Crohn's disease, history of chronic diarrheal diseases such as irritable bowel syndrome; history of sarcoidosis Medical history or history of tuberculosis; history of active hepatitis B, hepatitis C and HIV infection; Patients with allergic reactions to human or camel-derived monoclonal antibodies; Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders; Pleural effusion or ascites with clinical symptoms requiring clinical intervention; According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study;
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221006
About this study
Official title: A Single-arm Phase II Study of Envafolimab Combined With Endostar and Nab-paclitaxel Plus Gemcitabine for First-line Treatment of Advanced Pancreatic Cancer
This is a single-arm, open-label, exploratory study to evaluate efficacy and safety of envafolimab combined with endostar and nab-paclitaxel plus gemcitabine for first-line treatment of advanced pancreatic cancer.
Read the detailed description
This study is a prospective, open-label, single-arm, exploratory clinical study.
Recruited 20 subjects who met the inclusion criteria and received Endostar+Envofolimab+Nab-paclitaxel/Gemcitabine (AG regimen) chemotherapy according to the study plan. Treatment duration and dose can be adjusted according to patient tolerance until disease progression or intolerable toxicity, or other conditions determined by the investigator. During the trial, the efficacy indicators and safety indicators were observed.
- Conditions
- Advanced Pancreatic Cancer
- Being tested
- Envafolimab, Endostar, Nab paclitaxel, Gemcitabine
- Keywords
- Advanced pancreatic cancer, Envafolimab, Endostar, AG regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnvafolimabDrug
Also called Immunotherapy
400mg,sc,d1,Q4W
EndostarDrug
Also called endostatin
210mg,CIV72h,d1-3,Q4W
Nab paclitaxelDrug
Also called Chemotherapy
125mg/m2,iv,d1,d8,Q4W
GemcitabineDrug
Also called Chemotherapy
1000mg/m2, iv,d1,d8,Q4W
| Study group | Role | What they receive |
|---|---|---|
| Envafolimab and Endostar plus AG regimen | Experimental | Envafolimab:400mg,sc,d1,Q4W; Endostar:210mg,CIV72h,d1-3,Q4W; Chemotherapy:AG (nab-paclitaxel:125mg/m2,iv,d1,d8,Q4W;gemcitabine:1000mg/m2, iv,d1,d8,Q4W). Receives: Drug: Envafolimab; Drug: Endostar; Drug: Nab paclitaxel; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate
Measured: 6 months
PFS
Progressives free survival
Measured: 6 months
Secondary outcomes (3)
OS
Overall survival
Measured: 12 months
DCR
disease controll rate
Measured: 12 months
AEs
Percentage of participants experiencing grade 3-5 adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298020
- Sponsor's protocol ID
- XYFY2022-ENVA001
- Status last verified
- Mar 2022
- First submitted
- 18 Mar 2022
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- 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 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Phase II Study of Envafolimab Combined With Endostar and Nab-paclitaxel Plus Gemcitabine for First-line Treatment of Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05298020
- Acronym / sponsor ID
- XYFY2022-ENVA001
- Conditions
- Advanced Pancreatic Cancer
- Keywords
- Advanced pancreatic cancer, Envafolimab, Endostar, AG regimen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 28 Mar 2022 (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.
This is a single-arm, open-label, exploratory study to evaluate efficacy and safety of envafolimab combined with endostar and nab-paclitaxel plus gemcitabine for first-line treatment of advanced pancreatic cancer.
Detailed description
This study is a prospective, open-label, single-arm, exploratory clinical study.
Recruited 20 subjects who met the inclusion criteria and received Endostar+Envofolimab+Nab-paclitaxel/Gemcitabine (AG regimen) chemotherapy according to the study plan. Treatment duration and dose can be adjusted according to patient tolerance until disease progression or intolerable toxicity, or other conditions determined by the investigator. During the trial, the efficacy indicators and safety indicators were observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Envafolimab and Endostar plus AG regimen | Experimental | Drug: Envafolimab, Drug: Endostar, Drug: Nab paclitaxel, Drug: GemcitabineEnvafolimab:400mg,sc,d1,Q4W; Endostar:210mg,CIV72h,d1-3,Q4W; Chemotherapy:AG (nab-paclitaxel:125mg/m2,iv,d1,d8,Q4W;gemcitabine:1000mg/m2, iv,d1,d8,Q4W). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pathologically proven pancreatic cancer ;
- Age ≥ 18 years old, gender is not limited ; Expected survival ≥ 3 months ; ECOG 0-1; At least one measurable objective tumor lesion by spiral CT examination, the maximum diameter ≥ 1cm(according to RECIST 1.1); No previous chemotherapy, radiotherapy, immunotherapy, targeted therapy; The function of major organs is good, that is, the relevant inspection indicators within 14 days before enrollment meet the following requirements:(Hemoglobin ≥ 90 g/L (no blood transfusion within 14 days);Neutrophil count > 1.5×109/L; Platelet count ≥ 100×109/L;Total bilirubin ≤ 1.5×ULN (upper limit of normal);Blood alanine aminotransferase (ALT) or blood aspartate aminotransferase (AST) ≤2.5×ULN; if liver metastases, ALT or AST ≤ 5×ULN;Endogenous creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula);Cardiac Doppler Ultrasound Assessment: Left Ventricular Ejection Fraction (LVEF) ≥ 50% );
Key exclusion criteria (1 listed)
- Patients with other malignant tumors in the past or at the same time, and those tumors that are judged by the investigator to not affect the patient's life in the short term can be excluded; Participated in clinical trials of other drugs within four weeks ; Patients with known CNS metastases or a history of CNS metastases prior to screening. For patients with clinically suspected central nervous system metastasis, CT or MRI examination must be performed within 28 days before enrollment to exclude central nervous system metastasis; Patients with a history of unstable angina pectoris; newly diagnosed angina pectoris within 3 months before screening or myocardial infarction events within 6 months before screening; arrhythmia (including QTcF: male ≥ 450 ms, female ≥ 470 ms) requires Long-term use of antiarrhythmic drugs and New York Heart Association class ≥ II cardiac insufficiency; Urine routine indicates urine protein ≥++ and confirmed 24-hour urine protein quantification >1.0 g; For female subjects: should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study treatment period; Serum or urine pregnancy test must be negative within 7 days and must be non-nursing. Male subjects: should be surgically sterilized, or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study treatment period; Have used immune targeted therapy drugs; Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; Infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other patients who need corticosteroids; History of chronic autoimmune diseases, such as systemic lupus erythematosus; history of inflammatory bowel disease such as ulcerative colitis, Crohn's disease, history of chronic diarrheal diseases such as irritable bowel syndrome; history of sarcoidosis Medical history or history of tuberculosis; history of active hepatitis B, hepatitis C and HIV infection; Patients with allergic reactions to human or camel-derived monoclonal antibodies; Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders; Pleural effusion or ascites with clinical symptoms requiring clinical intervention; According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of 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 |
|---|---|---|
| EnvafolimabAlso: Immunotherapy400mg,sc,d1,Q4W | Drug | Envafolimab and Endostar plus AG regimen |
| EndostarAlso: endostatin210mg,CIV72h,d1-3,Q4W | Drug | Envafolimab and Endostar plus AG regimen |
| Nab paclitaxelAlso: Chemotherapy125mg/m2,iv,d1,d8,Q4W | Drug | Envafolimab and Endostar plus AG regimen |
| GemcitabineAlso: Chemotherapy1000mg/m2, iv,d1,d8,Q4W | Drug | Envafolimab and Endostar plus AG regimen |
Primary outcome
ORR
Time frame: 6 months
Objective response rate
PFS
Time frame: 6 months
Progressives free survival
3 secondary outcomes
OS
Time frame: 12 months
DCR
Time frame: 12 months
AEs
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- 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.
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 Envafolimab, Endostar and Nab paclitaxel in people with Advanced Pancreatic Cancer, run by The Affiliated Hospital of Xuzhou Medical 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 2 inclusion and 1 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 28 Mar 2022. 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 Zhengxiang Han, MD (18052268612, cnhzxyq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 6 months). 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 28 Mar 2022.