Pancreatic CancerPhase 2NCT06621095
Anlotinib Plus Benmelstobart and AG in First-line Treatment of Advanced Metastatic Pancreatic Cancer (ALTER-PA-001)
A Phase 2 study testing anlotinib + benmelstobart + nab-paclitaxel + gemcitabine and nab-paclitaxel + gemcitabine in people with Pancreatic Cancer and First-line, run by RenJi Hospital at 1 site in China.
Trial summary
This study is designed to explore the efficacy and safety of anlotinib combined with benmelstobart and AG (nab-paclitaxel and gemcitabine) as first-line treatment compared with AG (nab-paclitaxel and gemcitabine) in metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer, First-line, Metastatic Pancreatic Cancer
- What is being tested?
- anlotinib + benmelstobart + nab-paclitaxel + gemcitabine and nab-paclitaxel + gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2024to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- 18-75 years old (including 18 and 75 years old);
- Histologically or cytologically confirmed diagnosis of metastatic pancreatic cancer;
- No prior systemic therapy for metastatic pancreatic cancer (allowable circumstances for inclusion include recurrence more than 6 months after neoadjuvant (chemo)radiotherapy plus radical surgery, or recurrence more than 6 months after the completion of adjuvant (chemo)radiotherapy or radical concurrent chemoradiotherapy);
- At least one measurable lesion according to RECIST v1.1 criteria (any previous radiotherapy-treated lesion that has not progressed cannot be selected as the target lesion);
- Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;
- Life expectancy ≥ 3 months;
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- Adequate organ and bone marrow function, meeting the following criteria (within 7 days before enrollment):
- Hematology:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L Platelet count (PLT) ≥ 90 x 10^9/L Hemoglobin (HB) ≥ 90 g/L
- Biochemistry:
- Without liver metastasis: Serum total bilirubin (TBIL) ≤ 1.5x the upper limit of normal (ULN); with liver metastasis: TBIL ≤ 2.5 x ULN.
- Without liver metastasis: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN; with liver metastasis: ALT and AST ≤ 5 x ULN.
- Serum creatinine ≤ 1.5 x ULN and creatinine clearance rate ≥ 60 mL/min (calculated by the Cockcroft-Gault formula).
- Adequate coagulation function, defined as an international normalized ratio (INR) or a partial thromboplastin time (APTT) ≤ 1.5 x ULN.
- Women of childbearing age need to take effective contraceptive measures.
Who cannot join
- Previously received treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors or immune checkpoint inhibitors;
- Received other systemic antitumor treatments within 4 weeks prior to enrollment, including chemotherapy, signal transduction inhibitors, hormone therapy, biological immunotherapy, targeted therapy, photodynamic therapy, and traditional Chinese medicine with clear antitumor indications;
- Have other untreated or concurrent malignancies (excluding cervical carcinoma in situ, well-controlled basal cell or squamous cell carcinoma of the skin, or malignancy that has been treated and has shown no signs or evidence of recurrence for more than 3 years, and patients who do not require systemic therapy at the time of signing informed consent);
- Presence of central nervous system (CNS) metastases or brain metastases before enrollment;
- Underwent any surgery (excluding biopsy), invasive treatment or operation without complete healing of surgical incisions within 4 weeks before enrollment (excluding venous catheter placement and puncture drainage);
- Received radiotherapy within 4 weeks before enrollment (allowable if at least 2 weeks have passed since palliative radiotherapy for bone lesions was completed before starting study medication);
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- Previously received any organ transplantation;
- Clinically symptomatic ascites, pleural effusion, or pericardial effusion requiring puncture or drainage, or received drainage of effusions within 14 days before the first dose;
- International normalized ratio (INR) > 1.5 or partial thromboplastin time (APTT) > 1.5 x ULN;
- Clinically significant electrolyte abnormalities as determined by the investigator;
- Presence of active gastrointestinal diseases like active gastric and duodenal ulcers, ulcerative colitis, or unremoved tumors with active bleeding, or other conditions judged by the investigator to possibly cause gastrointestinal bleeding or perforation;
- Evidence or history of significant bleeding tendency or episodes within 3 months before enrollment (bleeding >30 mL, hematemesis, melena, or hematochezia), hemoptysis (> 5 mL of fresh blood within 4 weeks), or thromboembolic events such as stroke and/or transient ischemic attack within 12 months;
- Any severe and/or uncontrollable disease, including:
- History or presence of interstitial lung disease, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, severely impaired lung function, or other conditions that may interfere with the detection and management of suspected drug-related pulmonary toxicity.
- Clinically significant history of liver diseases, including active hepatitis (Hepatitis B reference: HBsAg positive with HBV DNA > 1 x 10^4 copies/mL or > 2000 IU/mL; Hepatitis C reference: HCV antibody positive with HCV RNA > 1 x 10^3 copies/mL), or other hepatitis, clinically significant moderate to severe hepatic cirrhosis; Note: Participants with eligible Hepatitis B or C must receive continuous antiviral treatment to prevent viral reactivation.
- Human immunodeficiency virus (HIV) antibody positivity.
- Uncontrolled hypertension (defined as systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg not controlled by medications);
- Poorly controlled cardiovascular clinical symptoms or diseases, including but not limited to acute myocardial infarction, malignant arrhythmias (including QTc > 450 ms for males and > 470 ms for females), ≥ Grade II congestive heart failure (New York Heart Association (NYHA) classification), or clinically significant abnormal myocardial enzyme levels as determined by the investigator;
- Active or uncontrollable severe infections (≥ NCI-CTC AE Grade 2 infections);
- Poorly controlled diabetes (fasting blood glucose (FBG) > 10 mmol/L);
- Proteinuria ≥ ++ on urinalysis and confirmed 24-hour urinary protein > 1.0 g;
- History or presence of autoimmune diseases, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener's granulomatosis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, autoimmune hepatitis, systemic sclerosis, Hashimoto's thyroiditis, autoimmune vasculitis, or autoimmune neuropathies (e.g., Guillain-Barre syndrome). Exceptions include stable hypothyroidism requiring hormone replacement therapy (including hypothyroidism due to autoimmune thyroid disease), psoriasis or vitiligo not requiring systemic treatment;
- Pregnant or breastfeeding women;
- Known history of allergy to investigational drug components;
- Participation in other clinical trials and treatment with investigational drugs within 4 weeks before enrollment;
- Any disease or condition that affects drug absorption or the inability of participants to take oral medications;
- Any other conditions judged by the investigator to be unsuitable for enrollment, including diseases, metabolic disorders, abnormal physical examination, laboratory result abnormalities, or any other conditions affecting the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Anlotinib Plus Benmelstobart and AG Versus AG in First-line Treatment of Advanced Metastatic Pancreatic Cancer: a Prospective, Randomized Controlled Clinical Trial (ALTER-PA-001)
This study is designed to explore the efficacy and safety of anlotinib combined with benmelstobart and AG (nab-paclitaxel and gemcitabine) as first-line treatment compared with AG (nab-paclitaxel and gemcitabine) in metastatic pancreatic cancer.
Read the detailed description
This is an open-label, multicenter, randomized controlled clinical trial. We plan to recruit 104 subjects and randomly assign them in a 2:1 ratio to either the experimental group receiving Anlotinib plus Benmelstobart plus Gemcitabine and Nab-Paclitaxel, or the control group receiving Gemcitabine and Nab-Paclitaxel as initial treatment. Each cycle of the aforementioned drugs will last three weeks, with tumor efficacy assessments conducted at the end of cycles 2, 4, 6, and 8. After 8 cycles of treatment, patients in the experimental group who achieve complete response (CR), partial response (PR), or stable disease (SD) will continue with maintenance therapy using Anlotinib plus Benmelstobart plus Gemcitabine. Similarly, after 8 cycles of treatment, patients in the control group who achieve CR, PR, or SD will continue with maintenance therapy using Gemcitabine monotherapy. Efficacy will be evaluated every 3 cycles (9 weeks) during the maintenance phase until disease progression or intolerability. This study aims to evaluate the efficacy and safety of the combination of Anlotinib and Benmelstobart with Gemcitabine and Nab-Paclitaxel in treating metastatic pancreatic cancer, providing a new treatment option for first-line therapy in patients with advanced metastatic pancreatic cancer.
- Conditions
- Pancreatic Cancer, First-line, Metastatic Pancreatic Cancer
- Being tested
- anlotinib + benmelstobart + nab-paclitaxel + gemcitabine, nab-paclitaxel + gemcitabine
- Keywords
- Metastatic Pancreatic Cancer, First-line, Immunotherapy, Angiogenesis inhibitors, Anlotinib
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anlotinib + benmelstobart + nab-paclitaxel + gemcitabineDrug
- Before 8 cycles, anlotinib 8mg, po.qd, d1-14; benmelstobart: 1200mg, I.V., D1, Q3W; nab-paclitaxel: 125mg/m2, I.V., D1, D8, Q3W; gemcitabine: 1000/m2, ivgtt for more than 30min, D1, D8, Q3W. The above schemes are repeated every three weeks.
- After 8 cycles, the regimen is changed to anlotinib 8mg, po.qd, d1-14; benmelstobart: 1200mg, I.V., D1, Q3W; gemcitabine: 1000/m2, ivgtt for more than 30min, D1, D8, Q3W. The regimen is repeated every 3 weeks until the disease progresses or unacceptable toxicity.
nab-paclitaxel + gemcitabineDrug
- Before 8 cycles, nab-paclitaxel: 125mg/m2, I.V., D1, D8, Q3W; gemcitabine: 1000/m2, ivgtt for more than 30min, D1, D8, Q3W. The above schemes are repeated every three weeks.
- After 8 cycles, the regimen is changed to gemcitabine: 1000/m2, ivgtt for more than 30min, D1, D8, Q3W. The regimen is repeated every 3 weeks until the disease progresses or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| anlotinib + benmelstobart + nab-paclitaxel + gemcitabine | Experimental | Initial treatment: anlotinib + benmelstobart + nab-paclitaxel + gemcitabine. Maintenance treatment (after 8 cycles): anlotinib + benmelstobart + gemcitabine. Receives: Drug: anlotinib + benmelstobart + nab-paclitaxel + gemcitabine |
| nab-paclitaxel + gemcitabine | Active comparator | Initial treatment: nab-paclitaxel + gemcitabine. Maintenance treatment (after 8 cycles): gemcitabine. Receives: Drug: nab-paclitaxel + gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The proportion of patients with complete response or partial response, using RESIST v1.1
Measured: Up to 24 months
Secondary outcomes (5)
Progression-Free Survival (PFS)
Time from first-dose to the first documented disease progression or death
Measured: Up to 24 months
Disease Control Rate (DCR)
The proportion of patients with complete response, partial response or stable disease, using RESIST v1.1
Measured: Up to 24 months
Duration of Response (DoR)
Duration of response according to RECIST v1.1 (Response was assessed with CT or MRI using RECIST v1.1, Duration of response (DoR): DoR will only be performed in subjects who have a confirmed tumor response (CR or PR) after treatment
Measured: Up to 24 months
Overall Survival (OS)
Overall Survival (OS) is defined as the time from enrollment to death from any cause.
Measured: Up to 24 months
Safety and tolerability by incidence, severity and outcome of adverse events
Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0
Measured: Until 30 day safety follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start30 Oct 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by RenJi 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
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Principal investigator, liwei wang, RenJi Hospital
- Investigators
- Liwei Wang, M.D., Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621095
- Sponsor's protocol ID
- LY2024-195-B
- Status last verified
- Sep 2024
- First submitted
- 27 Sep 2024
- Last updated
- 1 Oct 2024
- 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 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anlotinib Plus Benmelstobart and AG Versus AG in First-line Treatment of Advanced Metastatic Pancreatic Cancer: a Prospective, Randomized Controlled Clinical Trial (ALTER-PA-001)
- ClinicalTrials.gov ID
- NCT06621095
- Acronym / sponsor ID
- LY2024-195-B
- Conditions
- Pancreatic Cancer, First-line, Metastatic Pancreatic Cancer
- Keywords
- Metastatic Pancreatic Cancer, First-line, Immunotherapy, Angiogenesis inhibitors, Anlotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Oct 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 study is designed to explore the efficacy and safety of anlotinib combined with benmelstobart and AG (nab-paclitaxel and gemcitabine) as first-line treatment compared with AG (nab-paclitaxel and gemcitabine) in metastatic pancreatic cancer.
Detailed description
This is an open-label, multicenter, randomized controlled clinical trial. We plan to recruit 104 subjects and randomly assign them in a 2:1 ratio to either the experimental group receiving Anlotinib plus Benmelstobart plus Gemcitabine and Nab-Paclitaxel, or the control group receiving Gemcitabine and Nab-Paclitaxel as initial treatment. Each cycle of the aforementioned drugs will last three weeks, with tumor efficacy assessments conducted at the end of cycles 2, 4, 6, and 8. After 8 cycles of treatment, patients in the experimental group who achieve complete response (CR), partial response (PR), or stable disease (SD) will continue with maintenance therapy using Anlotinib plus Benmelstobart plus Gemcitabine. Similarly, after 8 cycles of treatment, patients in the control group who achieve CR, PR, or SD will continue with maintenance therapy using Gemcitabine monotherapy. Efficacy will be evaluated every 3 cycles (9 weeks) during the maintenance phase until disease progression or intolerability. This study aims to evaluate the efficacy and safety of the combination of Anlotinib and Benmelstobart with Gemcitabine and Nab-Paclitaxel in treating metastatic pancreatic cancer, providing a new treatment option for first-line therapy in patients with advanced metastatic pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anlotinib + benmelstobart + nab-paclitaxel + gemcitabine | Experimental | Drug: anlotinib + benmelstobart + nab-paclitaxel + gemcitabineInitial treatment: anlotinib + benmelstobart + nab-paclitaxel + gemcitabine. Maintenance treatment (after 8 cycles): anlotinib + benmelstobart + gemcitabine. |
| nab-paclitaxel + gemcitabine | Active comparator | Drug: nab-paclitaxel + gemcitabineInitial treatment: nab-paclitaxel + gemcitabine. Maintenance treatment (after 8 cycles): gemcitabine. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 18-75 years old (including 18 and 75 years old);
- Histologically or cytologically confirmed diagnosis of metastatic pancreatic cancer;
- No prior systemic therapy for metastatic pancreatic cancer (allowable circumstances for inclusion include recurrence more than 6 months after neoadjuvant (chemo)radiotherapy plus radical surgery, or recurrence more than 6 months after the completion of adjuvant (chemo)radiotherapy or radical concurrent chemoradiotherapy);
- At least one measurable lesion according to RECIST v1.1 criteria (any previous radiotherapy-treated lesion that has not progressed cannot be selected as the target lesion);
- Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;
Key exclusion criteria (27 listed)
- Previously received treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors or immune checkpoint inhibitors;
- Received other systemic antitumor treatments within 4 weeks prior to enrollment, including chemotherapy, signal transduction inhibitors, hormone therapy, biological immunotherapy, targeted therapy, photodynamic therapy, and traditional Chinese medicine with clear antitumor indications;
- Have other untreated or concurrent malignancies (excluding cervical carcinoma in situ, well-controlled basal cell or squamous cell carcinoma of the skin, or malignancy that has been treated and has shown no signs or evidence of recurrence for more than 3 years, and patients who do not require systemic therapy at the time of signing informed consent);
- Presence of central nervous system (CNS) metastases or brain metastases before enrollment;
- Underwent any surgery (excluding biopsy), invasive treatment or operation without complete healing of surgical incisions within 4 weeks before enrollment (excluding venous catheter placement and puncture drainage);
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 + benmelstobart + nab-paclitaxel + gemcitabine1. Before 8 cycles, anlotinib 8mg, po.qd, d1-14; benmelstobart: 1200mg, I.V., D1, Q3W; nab-paclitaxel: 125mg/m2, I.V., D1, D8, Q3W; gemcitabine: 1000/m2, ivgtt for more than 30min, D1, D8, Q3W. The above schemes are repeated every three weeks. 2. After 8 cycles, the regimen is changed to anlotinib 8mg, po.qd, d1-14; benmelstobart: 1200mg, I.V., D1, Q3W; gemcitabine: 1000/m2, ivgtt for more than 30min, D1, D8, Q3W. The regimen is repeated every 3 weeks until the disease progresses or unacceptable toxicity. | Drug | anlotinib + benmelstobart + nab-paclitaxel + gemcitabine |
| nab-paclitaxel + gemcitabine1. Before 8 cycles, nab-paclitaxel: 125mg/m2, I.V., D1, D8, Q3W; gemcitabine: 1000/m2, ivgtt for more than 30min, D1, D8, Q3W. The above schemes are repeated every three weeks. 2. After 8 cycles, the regimen is changed to gemcitabine: 1000/m2, ivgtt for more than 30min, D1, D8, Q3W. The regimen is repeated every 3 weeks until the disease progresses or unacceptable toxicity. | Drug | nab-paclitaxel + gemcitabine |
Primary outcome
Objective response rate (ORR)
Time frame: Up to 24 months
The proportion of patients with complete response or partial response, using RESIST v1.1
5 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Up to 24 months
Disease Control Rate (DCR)
Time frame: Up to 24 months
Duration of Response (DoR)
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 24 months
Safety and tolerability by incidence, severity and outcome of adverse events
Time frame: Until 30 day safety follow-up visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- 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.
Liwei Wang, M.D. principal investigator
RenJi 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 anlotinib + benmelstobart + nab-paclitaxel + gemcitabine and nab-paclitaxel + gemcitabine in people with Pancreatic Cancer and First-line, run by RenJi 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 15 inclusion and 27 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: opening soon, as of the sponsor's last update on 1 Oct 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liwei Wang, M.D. (021-58752345, lwwang2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to 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 1 Oct 2024.