Health TrialsbyHealthPanel

Anlotinib Plus Benmelstobart and AG in First-line Treatment of Advanced Metastatic Pancreatic Cancer (ALTER-PA-001)

ConditionsPancreatic CancerFirst-lineMetastatic Pancreatic Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRenJi Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • anlotinib + benmelstobart + nab-paclitaxel + gemcitabine

    Drug

    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 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 + gemcitabine

    Drug

    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 more than 30min, D1, D8, Q3W. The regimen is repeated every 3 weeks until the disease progresses or unacceptable toxicity.

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: anlotinib + benmelstobart + nab-paclitaxel + gemcitabineExperimental treatment 1 intervention
Group B: nab-paclitaxel + gemcitabineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

The proportion of patients with complete response or partial response, using RESIST v1.1

Time frame
Up to 24 months

Secondary outcomes

1

Progression-Free Survival (PFS)

Time from first-dose to the first documented disease progression or death

Time frame
Up to 24 months
2

Disease Control Rate (DCR)

The proportion of patients with complete response, partial response or stable disease, using RESIST v1.1

Time frame
Up to 24 months
3

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

Time frame
Up to 24 months
4

Overall Survival (OS)

Overall Survival (OS) is defined as the time from enrollment to death from any cause.

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenJi Hospital

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: