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
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
Treatments tested in this trial
- Anlotinib and Benmelstobart
Treatment groups
22 Participants
are divided into 1 treatment groupSponsors and collaborators
Sun Yat-sen University
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborator
Source ClinicalTrials.gov