Overall SurvivalPhase 2NCT05218629
Anlotinib Plus PD-1 Inhibitor as 2nd-line Threapy in Patients With Metastatic Pancreatic Cancer
A Phase 2 study testing Anlotinib, PD-1 inhibitor in people with Overall Survival, run by Qingdao Central Hospital at 2 sites in China.
Trial summary
This research study is a Phase 2 clinical trial. It will test the efficiency and safety of an investigational drug of Anlotinib (a small molecular anti-VEGF TKI) with PD-1 inhibitor in second-line therapy with the goal of determining the OS of metastatic pancreatic adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Overall Survival
- What is being tested?
- Anlotinib, PD-1 inhibitor
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2022to 30 Jun 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cytologically- or histologically-confirmed pancreatic adenocarcinoma or poorly differentiated pancreatic carcinoma that is metastatic to distant sites. • Other histologies such as neuroendocrine and acinar cell carcinoma are excluded. Enrolled patients are all failed to first-line chemotherapy • Patients are eligible if they received adjuvant treatment after surgical resection • Participants are required to have measurable disease (RECIST v1.1), defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral CT scan. See section 11 for the evaluation of measurable disease. • Participants enrolled must have disease that is accessible for tumor biopsies and must agree to a pre-treatment tumor biopsy. • Age ≥ 18 years. Because no dosing or adverse event data are currently available in participants <18 years of age, children are excluded from this study but will be eligible for future pediatric trials. • ECOG performance status ≤2 (see Appendix A) • Patients must have completed any major surgery or open biopsy ≥4 weeks from start of treatment. • Participants must have adequate organ and marrow function as defined below: o Absolute neutrophil count ≥1,500/mcL o Platelets ≥100,000/mcL o Total bilirubin ≤1.5 × institutional upper limit of normal o AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal o Creatinine ≤1.5 × institutional upper limit of normal OR o Creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above 1.5 × upper limit of normal. • Negative serum pregnancy test for women of childbearing potential. • Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Concurrent use of any other anti-cancer therapy, including chemotherapy, targeted therapy, immunotherapy, or biological agents. • Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Screening for brain metastases with head imaging is not required. • History of allergic reactions attributed to compounds of similar chemical or biologic composition to above drugs or other agents used in study. • History of prior or current synchronous malignancy, except: o Malignancy that was treated with curative intent and for which there has been no known active disease for >3 years prior to enrollment • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, NYHA class III/IV congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Qingdao central Hospital
Qingdao, Shandong, 266042
Youxin Ji, MD, 68665078, ji6677@gmail.com
- Recruiting
Qingdao central Hospital
Qingdao, Shandong, 266042
kevin ji, 053268665078, kevinji78@163.com
About this study
Official title: Phase 2 Study of Anlotinib With PD-1 Inhibitor as Second Line Therapy in the Treatment of Metastatic Pancreatic Cancer
This research study is a Phase 2 clinical trial. It will test the efficiency and safety of an investigational drug of Anlotinib (a small molecular anti-VEGF TKI) with PD-1 inhibitor in second-line therapy with the goal of determining the OS of metastatic pancreatic adenocarcinoma. Subjects must have a stage 4 untreated metastatic pancreatic ductal cancer failed to first-line chemotherapy and meet all inclusion/exclusion criteria. Treatment consists of treatment with anlotinib 8-12 mg oral, day 1-14, and PD-1 inhibitor 200 mg iv, every 21 days each cycle. Treatment will be administered until untolerable toxicities or progression or subject death, or either the subject or sponsor discontinues the study.
- Conditions
- Overall Survival
- Being tested
- Anlotinib, PD-1 inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib, PD-1 inhibitorDrug
Anlotinib, 8-12 mg/day, orally, day 1-14; PD-1 inhibitor 200 mg iv, every 21 days one cycle
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib， PD-1inhibitor | Experimental | Anlotinib 8-14 mg, oral, once a day for 14 days every 3 weeks. PD-1 inhibitor (Pembrolizumab) 200mg iv day1, every 3 weeks Receives: Drug: Anlotinib, PD-1 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall survival in this population of patients
The overall survival of the enrolled patients from start the combination treatment of anlotinib and PD-1 inhibitor
Measured: 24 months
Secondary outcomes (2)
The progression free survival in this population of patients
The progression free survival of the enrolled patients from start the combination treatment with anlotinib and PD-1 inhibitor
Measured: 24 months
The response rate in this population of patients
Number of participants with clinical response assessed by RECIST 1.1 criteria on imaging every 4 weeks with the combination of anlotinib and PD-1 inhibitor
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overall SurvivalStudies 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
- Qingdao Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218629
- Sponsor's protocol ID
- QDCH2022-01-18
- Status last verified
- Mar 2023
- First submitted
- 17 Jan 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Anlotinib With PD-1 Inhibitor as Second Line Therapy in the Treatment of Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05218629
- Acronym / sponsor ID
- QDCH2022-01-18
- Conditions
- Overall Survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Qingdao Central HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 1 Feb 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 research study is a Phase 2 clinical trial. It will test the efficiency and safety of an investigational drug of Anlotinib (a small molecular anti-VEGF TKI) with PD-1 inhibitor in second-line therapy with the goal of determining the OS of metastatic pancreatic adenocarcinoma. Subjects must have a stage 4 untreated metastatic pancreatic ductal cancer failed to first-line chemotherapy and meet all inclusion/exclusion criteria. Treatment consists of treatment with anlotinib 8-12 mg oral, day 1-14, and PD-1 inhibitor 200 mg iv, every 21 days each cycle. Treatment will be administered until untolerable toxicities or progression or subject death, or either the subject or sponsor discontinues the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib， PD-1inhibitor | Experimental | Drug: Anlotinib, PD-1 inhibitorAnlotinib 8-14 mg, oral, once a day for 14 days every 3 weeks. PD-1 inhibitor (Pembrolizumab) 200mg iv day1, every 3 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cytologically- or histologically-confirmed pancreatic adenocarcinoma or poorly differentiated pancreatic carcinoma that is metastatic to distant sites. • Other histologies such as neuroendocrine and acinar cell carcinoma are excluded. Enrolled patients are all failed to first-line chemotherapy • Patients are eligible if they received adjuvant treatment after surgical resection • Participants are required to have measurable disease (RECIST v1.1), defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral CT scan. See section 11 for the evaluation of measurable disease. • Participants enrolled must have disease that is accessible for tumor biopsies and must agree to a pre-treatment tumor biopsy. • Age ≥ 18 years. Because no dosing or adverse event data are currently available in participants <18 years of age, children are excluded from this study but will be eligible for future pediatric trials. • ECOG performance status ≤2 (see Appendix A) • Patients must have completed any major surgery or open biopsy ≥4 weeks from start of treatment. • Participants must have adequate organ and marrow function as defined below: o Absolute neutrophil count ≥1,500/mcL o Platelets ≥100,000/mcL o Total bilirubin ≤1.5 × institutional upper limit of normal o AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal o Creatinine ≤1.5 × institutional upper limit of normal OR o Creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above 1.5 × upper limit of normal. • Negative serum pregnancy test for women of childbearing potential. • Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (1 listed)
- Concurrent use of any other anti-cancer therapy, including chemotherapy, targeted therapy, immunotherapy, or biological agents. • Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Screening for brain metastases with head imaging is not required. • History of allergic reactions attributed to compounds of similar chemical or biologic composition to above drugs or other agents used in study. • History of prior or current synchronous malignancy, except: o Malignancy that was treated with curative intent and for which there has been no known active disease for >3 years prior to enrollment • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, NYHA class III/IV congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| Anlotinib, PD-1 inhibitorAnlotinib, 8-12 mg/day, orally, day 1-14; PD-1 inhibitor 200 mg iv, every 21 days one cycle | Drug | Anlotinib， PD-1inhibitor |
Primary outcome
The overall survival in this population of patients
Time frame: 24 months
The overall survival of the enrolled patients from start the combination treatment of anlotinib and PD-1 inhibitor
2 secondary outcomes
The progression free survival in this population of patients
Time frame: 24 months
The response rate in this population of patients
Time frame: Up to 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: Yes
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib, PD-1 inhibitor in people with Overall Survival, run by Qingdao Central Hospital at 2 sites 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 1 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 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall survival in this population of patients (time frame: 24 months). 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 29 Mar 2023.