Anlotinib Plus Benmelstobart And AG In First-line Treatment Of Advanced Metastatic Pancreatic Cancer (ALTER-PA-001)

Study Overview

Anlotinib Plus Benmelstobart and AG in First-line Treatment of Advanced Metastatic Pancreatic Cancer (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.

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.

Pancreatic Cancer
First-line
Metastatic Pancreatic Cancer

DRUG: anlotinib + benmelstobart + nab-paclitaxel + gemcitabine
DRUG: nab-paclitaxel + gemcitabine

LY2024-195-B

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-09-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-09-27
First Submitted that Met QC Criteria 2024-09-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-10-01
First Posted (ACTUAL) 2024-10-01	Results First Posted N/A	Last Verified 2024-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: anlotinib + benmelstobart + nab-paclitaxel + gemcitabine Initial treatment: anlotinib + benmelstobart + nab-paclitaxel + gemcitabine. Maintenance treatment (after 8 cycles): anlotinib + benmelstobart + gemcitabine.	DRUG: anlotinib + benmelstobart + nab-paclitaxel + gemcitabine 1. 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
ACTIVE_COMPARATOR: nab-paclitaxel + gemcitabine Initial treatment: nab-paclitaxel + gemcitabine. Maintenance treatment (after 8 cycles): gemcitabine.	DRUG: anlotinib + benmelstobart + nab-paclitaxel + gemcitabine 1. 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 DRUG: nab-paclitaxel + gemcitabine 1. 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 m

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: anlotinib + benmelstobart + nab-paclitaxel + gemcitabine

Initial treatment: anlotinib + benmelstobart + nab-paclitaxel + gemcitabine. Maintenance treatment (after 8 cycles): anlotinib + benmelstobart + gemcitabine.

DRUG: anlotinib + benmelstobart + nab-paclitaxel + gemcitabine

1. 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

ACTIVE_COMPARATOR: nab-paclitaxel + gemcitabine

Initial treatment: nab-paclitaxel + gemcitabine. Maintenance treatment (after 8 cycles): gemcitabine.

DRUG: anlotinib + benmelstobart + nab-paclitaxel + gemcitabine

1. 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

DRUG: nab-paclitaxel + gemcitabine

1. 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 m

Primary Outcome Measures	Measure Description	Time Frame
Objective response rate (ORR)	The proportion of patients with complete response or partial response, using RESIST v1.1	Up to 24 months

Secondary Outcome Measures	Measure Description	Time Frame
Progression-Free Survival (PFS)	Time from first-dose to the first documented disease progression or death	Up to 24 months
Disease Control Rate (DCR)	The proportion of patients with complete response, partial response or stable disease, using RESIST v1.1	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	Up to 24 months
Overall Survival (OS)	Overall Survival (OS) is defined as the time from enrollment to death from any cause.	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	Until 30 day safety follow-up visit

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Liwei Wang, M.D.

Phone Number: 021-58752345

Email: lwwang2013@163.com

Study Contact Backup

Name: Jiujie Cui, M.D.

Phone Number: 13621958524

Email: cuijiujie@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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;
Adequate organ and bone marrow function, meeting the following criteria (within 7 days before enrollment):

Women of childbearing age need to take effective contraceptive measures.

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);
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:

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

PRINCIPAL_INVESTIGATOR: Liwei Wang, M.D., RenJi Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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