AnlotinibPhase 1/2NCT04803851
Anlotinib Plus Anti-PD-1 Antibody AK105 for Advanced Pancreatic Cancer
A Phase 1/2 study testing Anlotinib plus AK105 in people with Anlotinib and Anti-PD-1 Antibody, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study was designed to explore the clinical efficacy of Anlotinib combined with Anti-PD-1 antibody AK105 in the treatment of third- and above -line advanced pancreatic cancer patients, in order to find a better therapy strategy for pancreatic cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anlotinib, Anti-PD-1 Antibody, Advanced Pancreatic Cancer
- What is being tested?
- Anlotinib plus AK105
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2021to 29 Jun 2024
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- locally advanced or metastatic pancreatic cancer (PC),
- histologically or cytologically proven diagnosis of adenocarcinoma or adenosquamous carcinoma,
- failed to second-line chemotherapy for PC,
- 18-75 years of age,
- an Eastern Cooperative Oncology Group performance status score of 0 to 1,
- adequate organ functions
Who cannot join
- had received PD 1 /CTLA 4 antibody treatment
- had received anti-VEGFR inhibitors or antibodies
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100032
Xiang Wang, Doctor, 011-86-10-69151279, wangxiang5123@126.com
About this study
Official title: Anlotinib Plus Anti-PD-1 Antibody AK105 as Third or More-line Therapy for Advanced Pancreatic Cancer: a Prospective, Single-arm, Open-label, Pilot Study
This study was designed to explore the clinical efficacy of Anlotinib combined with Anti-PD-1 antibody AK105 in the treatment of third- and above -line advanced pancreatic cancer patients, in order to find a better therapy strategy for pancreatic cancer patients.
- Conditions
- Anlotinib, Anti-PD-1 Antibody, Advanced Pancreatic Cancer
- Being tested
- Anlotinib plus AK105
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib plus AK105Drug
Anlotinib： a multi-kinase inhibitor AK105： an anti-PD-1 antibody
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Anlotinib plus AK105 Receives: Drug: Anlotinib plus AK105 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate (DCR) based on RECIST v. 1 1
Disease control rate (DCR) based on RECIST v. 1 1 by investigators
Measured: 6 weeks
Secondary outcomes (4)
Objective response rate (ORR) based on RECIST V. 1.1
Objective response rate (ORR) based on RECIST V. 1.1 by investigators
Measured: 6 weeks
Progression free survival (PFS) measured from the date of anlotinib plus AK105 initiation to the time of progression
Progression free survival (PFS) measured from the date of anlotinib plus AK105 initiation to the time of progression by investigators assessment
Measured: 6 weeks
Overall survival (OS) measured from the date of anlotinib plus AK105 initiation to the time of death of any cause
Overall survival (OS) measured from the date of anlotinib plus AK105 initiation to the time of death of any cause by investigators assessment
Measured: 6 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
adverse events assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start12 May 2021
- Primary completion28 Feb 2024 (estimated)
- Study completion29 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnlotinibStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803851
- Sponsor's protocol ID
- JS2791
- Status last verified
- Feb 2023
- First submitted
- 23 Feb 2021
- Last updated
- 22 Jun 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 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anlotinib Plus Anti-PD-1 Antibody AK105 as Third or More-line Therapy for Advanced Pancreatic Cancer: a Prospective, Single-arm, Open-label, Pilot Study
- ClinicalTrials.gov ID
- NCT04803851
- Acronym / sponsor ID
- JS2791
- Conditions
- Anlotinib, Anti-PD-1 Antibody, Advanced Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 29 Jun 2024 (estimated)
- First posted
- 18 Mar 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.
This study was designed to explore the clinical efficacy of Anlotinib combined with Anti-PD-1 antibody AK105 in the treatment of third- and above -line advanced pancreatic cancer patients, in order to find a better therapy strategy for pancreatic cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Anlotinib plus AK105Anlotinib plus AK105 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- locally advanced or metastatic pancreatic cancer (PC),
- histologically or cytologically proven diagnosis of adenocarcinoma or adenosquamous carcinoma,
- failed to second-line chemotherapy for PC,
- 18-75 years of age,
- an Eastern Cooperative Oncology Group performance status score of 0 to 1,
Key exclusion criteria (2 listed)
- had received PD 1 /CTLA 4 antibody treatment
- had received anti-VEGFR inhibitors or antibodies
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 plus AK105Anlotinib： a multi-kinase inhibitor AK105： an anti-PD-1 antibody | Drug | Treatment group |
Primary outcome
Disease control rate (DCR) based on RECIST v. 1 1
Time frame: 6 weeks
Disease control rate (DCR) based on RECIST v. 1 1 by investigators
4 secondary outcomes
Objective response rate (ORR) based on RECIST V. 1.1
Time frame: 6 weeks
Progression free survival (PFS) measured from the date of anlotinib plus AK105 initiation to the time of progression
Time frame: 6 weeks
Overall survival (OS) measured from the date of anlotinib plus AK105 initiation to the time of death of any cause
Time frame: 6 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Anlotinib
RecruitingPhase 2
Zemetostat With Anlotinib in Patients With Recurrent/Metastatic Head and Neck Soft Tissue Sarcoma
Soft Tissue Sarcoma
RecruitingPhase 2
Neoadjuvant Anlotinib and Epirubicin for T4 Sinonasal Adenoid Cystic Carcinoma
Adenoid Cystic Carcinoma
Not yet recruitingPhase 2
Risk-Adapted Anlotinib and PD-L1 for Locoregionally Advanced Nasopharyngeal Carcinoma
Nasopharyngeal Cancinoma (NPC)
RecruitingPhase 2
Pucotenlimab and Anlotinib in Combination With Chemotherapy
Breast Cancer
Active, not recruitingPhase 2
AK105 Combined With Anlotinib in Patients With Cervical Cancer
Cervical Cancer
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 1/2 study testing Anlotinib plus AK105 in people with Anlotinib and Anti-PD-1 Antibody, run by Peking Union Medical College 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 6 inclusion and 2 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 Jun 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 XIANG WANG, Master (86-1069158773, wangxiang5123@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control rate (DCR) based on RECIST v. 1 1 (time frame: 6 weeks). 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 Jun 2023.