Pancreatic CancerPhase 1/2NCT06278493
A Clinical Study of AL2846 Capsule Combined With Gemzar Injection in the Treatment of Advanced Pancreatic Cancer
A Phase 1/2 study testing AL2846 capsules and Gemzar in people with Pancreatic Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This is a clinical study to observe the tolerance and primary efficacy of AL2846 capsules combined with Gemzar injection in patients with pancreatic cancer, and to determine the recommended dosage and administration method for subsequent clinical studies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- AL2846 capsules and Gemzar
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2018to 1 May 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non operative patients with pancreatic cancer confirmed by histology or cytology, At least one evaluable lesion exists.
- ≥18 years old and ≤70 years old, Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1, expected survival period of more than 3 months.
- No chemotherapy or targeted treatment has been carried out for advanced pancreatic cancer, or more than half a year after the end of postoperative treatment.
- Normal function of major organs.
- Female subjects should agree to use contraception during the study period and within 6 months after the end of the study; Within 7 days prior to enrollment in the study, the serum or urine pregnancy test should be negative and must be a non lactating patient; Male subjects should agree to use contraceptive measures during the study period and within 6 months after the end of the study period.
- Subjects voluntarily participate in this study and sign informed consent.
Who cannot join
- Have any type of active malignant tumor or have a history of malignant tumor.
- Previously treated with Gemzar injection.
- Known brain metastases, spinal cord compression, cancerous meningitis, or diseases of the brain or pia mater detected during Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) screening.
- Clinically significant ascites in patients.
- Diarrhea greater than or equal to level 2.
- Have any acute or chronic active infectious disease.
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- Hypertensive patients who cannot be well controlled, or suffering from myocardial ischemia or myocardial infarction, arrhythmia, and grade I heart failure.
- Urine routine indicates urine protein ≥++, and it is confirmed that the 24-hour urine protein quantification is greater than 1.0 g.
- History of abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months.
- Long term unhealed wounds or fractures.
- Individuals who have experienced arterial/venous thrombosis events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism.
- Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; Under the premise that international normalized ratio (INR) is ≤ 1.5, it is allowed to use low-dose warfarin (1mg orally, once daily) or low-dose aspirin (not exceeding 100mg daily) for preventive purposes.
- Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders.
- Patients known to be allergic to Gemzar injection.
- Patients with active hepatitis B or hepatitis C.
- Individuals with a history of immunodeficiency, including HIV testing positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- According to the investigator's judgment, there are accompanying diseases that seriously endanger patient safety or affect the completion of the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, 300181
About this study
Official title: A Phase I/IIa Clinical Trial AL2846 Capsule Combined With Gemzar Injection in the Treatment of Advanced Pancreatic Cancer.
This is a clinical study to observe the tolerance and primary efficacy of AL2846 capsules combined with Gemzar injection in patients with pancreatic cancer, and to determine the recommended dosage and administration method for subsequent clinical studies.
- Conditions
- Pancreatic Cancer
- Being tested
- AL2846 capsules, Gemzar
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL2846 capsulesDrug
AL2846 is a multi -target receptor tyrosine kinase inhibitor.
GemzarDrug
It is a chemotherapeutic drug.
| Study group | Role | What they receive |
|---|---|---|
| AL2846 capsules + Gemzar injection | Experimental | AL2846 capsules combined with Gemzar injection,28 days as a treatment cycle Receives: Drug: AL2846 capsules; Drug: Gemzar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
One or more unacceptable toxic reactions that appear after administration cause the dose or extend the dose cycle that cannot continue to increase the dose or extend the dose
Measured: Up to 4 weeks.
Maximum tolerated dose (MTD)
If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered MTD.
Measured: Up to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start23 Aug 2018
- Primary completion25 Oct 2021
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278493
- Sponsor's protocol ID
- AL2846-I-0002
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu R, Ji Z, Wang X, Xin J, Zhu L, Ge S, Zhang L, Bai M, Ning T, Yang Y, Li H, Deng T, Ba Y. Efficacy and safety of multi-target tyrosine kinase inhibitor AL2846 combined with gemcitabine in pancreatic cancer. Invest New Drugs. 2025 Feb;43(1):81-92. doi: 10.1007/s10637-024-01485-5. Epub 2025 Jan 6.
PubMed 39760815
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Clinical Trial AL2846 Capsule Combined With Gemzar Injection in the Treatment of Advanced Pancreatic Cancer.
- ClinicalTrials.gov ID
- NCT06278493
- Acronym / sponsor ID
- AL2846-I-0002
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 26 Feb 2024 (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 clinical study to observe the tolerance and primary efficacy of AL2846 capsules combined with Gemzar injection in patients with pancreatic cancer, and to determine the recommended dosage and administration method for subsequent clinical studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AL2846 capsules + Gemzar injection | Experimental | Drug: AL2846 capsules, Drug: GemzarAL2846 capsules combined with Gemzar injection,28 days as a treatment cycle |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Non operative patients with pancreatic cancer confirmed by histology or cytology, At least one evaluable lesion exists.
- ≥18 years old and ≤70 years old, Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1, expected survival period of more than 3 months.
- No chemotherapy or targeted treatment has been carried out for advanced pancreatic cancer, or more than half a year after the end of postoperative treatment.
- Normal function of major organs.
- Female subjects should agree to use contraception during the study period and within 6 months after the end of the study; Within 7 days prior to enrollment in the study, the serum or urine pregnancy test should be negative and must be a non lactating patient; Male subjects should agree to use contraceptive measures during the study period and within 6 months after the end of the study period.
Key exclusion criteria (17 listed)
- Have any type of active malignant tumor or have a history of malignant tumor.
- Previously treated with Gemzar injection.
- Known brain metastases, spinal cord compression, cancerous meningitis, or diseases of the brain or pia mater detected during Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) screening.
- Clinically significant ascites in patients.
- Diarrhea greater than or equal to level 2.
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 |
|---|---|---|
| AL2846 capsulesAL2846 is a multi -target receptor tyrosine kinase inhibitor. | Drug | AL2846 capsules + Gemzar injection |
| GemzarIt is a chemotherapeutic drug. | Drug | AL2846 capsules + Gemzar injection |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: Up to 4 weeks.
One or more unacceptable toxic reactions that appear after administration cause the dose or extend the dose cycle that cannot continue to increase the dose or extend the dose
Maximum tolerated dose (MTD)
Time frame: Up to 4 weeks.
If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered MTD.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Derived from this study: PubMed 39760815Liu R, Ji Z, Wang X, Xin J, Zhu L, Ge S, Zhang L, Bai M, Ning T, Yang Y, Li H, Deng T, Ba Y. Efficacy and safety of multi-target tyrosine kinase inhibitor AL2846 combined with gemcitabine in pancreatic cancer. Invest New Drugs. 2025 Feb;43(1):81-92. doi: 10.1007/s10637-024-01485-5. Epub 2025 Jan 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 AL2846 capsules and Gemzar in people with Pancreatic Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. 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 17 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: finished, as of the sponsor's last update on 26 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: Up to 4 weeks.). 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?
On the ClinicalTrials.gov record for NCT06278493, which also lists 1 linked publication.
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 26 Feb 2024.