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Anlotinib Combined With Benmelstobart for Advanced Pheochromocytoma

ConditionPheochromocytoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

There is currently no standard first-line treatment for stage PPGL, and the 5-year survival rate of patients with advanced pheochromocytoma/paraganglioma (PPGL) is low, ranging from 30% to 60%. At present, several domestic teams have carried out clinical studies on the treatment of advanced PPGL with good efficacy. In the early stage, our center used anrotinib to treat advanced PPGL, and the overall effective rate reached 44%. In the early stage, our team used anrotinib combined with PD-1 monoclonal antibody to treat advanced PPGL patients. The effective rate reached 66% (2/3). Therefore, the investigators plan to further conduct prospective studies to explore the efficacy and safety of anlotinib combined with PD-1 monoclonal antibody in the treatment of advanced PPGL, so as to bring benefits to patients with advanced PPGL.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients voluntarily participate in this study and sign informed consent;

Patients aged ≥18 years and ≤75 years;

ECOG score ≤2 points; Expected survival ≥6 months;

Pathological diagnosis of advanced pheochromocytoma/paraganglioma: including clinical stage IV unresectable pheochromocytoma/paraganglioma with postoperative recurrence or metastasis;

Disqualifiers

known allergic reactions to anrotinib hydrochloride capsules, Benmelstobart active ingredients or any excipients;

Receiving anti-tumor monoclonal antibodies or other investigational drugs before enrollment; Previous treatment with other anti-PD-1 monoclonal antibodies or other medications targeting PD-1 / PD-L1;

previous use of anrotinib hydrochloride capsules or other anti-angiogenic drugs, such as Sunitinib, bevacizumab, etc.;

Patients were taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (doses greater than 10mg/day prednisone or other equivalent hormones) and were still taking them within 2 weeks prior to enrollment;

Trial design

Design model

Single group

Treatments tested in this trial

  • Anlotinib and Benmelstobart

    Drug

    Enrolled patients received a treatment cycle every 21 days: 200mg of piamprizumab was given intravenously on the first day of treatment, and 12mg of anrotinib hydrochloride capsule was given continuously for 14 days and suspended for 7 days.

Treatment groups

22 Participants
are divided into 1 treatment group
Group A: DrugExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate

The sum of the maximum tumor diameter decreased by ≥30%

Time frame
2years

Secondary outcomes

1

progression-free survival

The time before tumor diameters increased by less than 20%

Time frame
2years
2

Overall survival

The time before the patient died

Time frame
2years
3

Duration of remission

The duration of tumor remission

Time frame
2years
4

Clinical response rate

the number of patient with PR SD and CR

Time frame
2years

Other outcomes

Sponsors and contacts

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

Sun Yat-sen University

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: