Anlotinib Combined With Benmelstobart for Advanced Pheochromocytoma

NCT06429397 | Not Yet Recruiting Phase 2

• 1 other identifier: 2023-FXY-304
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pheochromocytoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate

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

  2years

Secondary Outcomes (4)

• progression-free survival

  2years

• Overall survival

  2years

• Duration of remission

  2years

• Clinical response rate

  2years

Study Arms (1)

Drug

EXPERIMENTAL

Patients receive Penpulimab and anlotinib

Drug: Anlotinib and Benmelstobart

Interventions

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.

Drug

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Unwilling or unsuitable for chemotherapy and radionuclide therapy.
• At least one measurable lesion (RECIST 1.1);
• The main organs function well, and the laboratory examination indicators meet:
• Blood routine examination:
• Hemoglobin (HB) ≥ 90g/L(5.6 mmol/L); Absolute neutrophil count (ANC) ≥1.5×109/L; Total white blood cells ≥3.5×109/L;
• ③ Platelet (PLT) ≥ 80×109/L;
• Blood biochemical examination:
• ① Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN (liver metastasis/bone metastasis ≤5 × ULN; Bone metastases ≤5 ULN);
• ② Serum total bilirubin (TBIL) ≤1.5 × ULN;
• ③ Serum creatinine Cr≤1.5×ULN or creatinine clearance ≥60 ml/min; Blood urea nitrogen (BUN)≤2.5 × upper limit of normal value (ULN);
• ④ Albumin (ALB)≥30 g/L;

You may not qualify if:

• 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;
• The patient has any active autoimmune disease or a history of autoimmune disease; Have clinical symptoms or diseases of the heart that are not well controlled;
• Congenital or acquired immune deficiency;
• History of gastrointestinal perforation or open biopsy within 4 weeks prior to enrollment; ≥CTCAE grade 3 for any bleeding event, presence of unhealed wounds, ulcers, or fractures;
• Hyperarterial/venous thrombosis events occurred within 6 months before the study period, such as non-cardiovascular and cerebrovascular events (including temporary ischemic attack), deep vein thrombosis (except venous thrombosis caused by intravenous catheterization during previous chemotherapy and cured by investigators), pulmonary embolism, etc.; Cardiac angioplasty or coronary bypass surgery for unstable arrhythmia, unstable angina pectoris or myocardial infarction;
• People with active bleeding or bleeding tendency;
• Patients suspected of having other primary cancers; Patients with other primary malignancies within the 5 years prior to the study (other than adequately treated cervical or skin cancer in situ, such as basal cell carcinoma, squamous cell carcinoma, or non-melanoma skin cancer);
• Combined diseases/medical history:
• Clinically significant hemoptysis (\> 50ml daily hemoptysis) occurred within 3 months prior to enrollment; Or clinically significant bleeding symptoms or definite bleeding tendencies, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, stool occult blood or above at baseline, or vasculitis;
• hypertension, which is not well controlled by antihypertensive drugs (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100mmHg); In the 6 months prior to randomization, the following conditions had occurred: myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or higher cardiac dysfunction, clinically significant supracentricular or ventricular arrhythmias, and symptomatic congestive heart failure;
• interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (such as poorly controlled diabetes (fasting blood glucose (FBG) \> 10mmol/ L), pulmonary fibrosis and acute pneumonia, etc.); Renal failure requires hemodialysis or peritoneal dialysis; Liver cirrhosis, decompensated liver disease, active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU/ml; Hepatitis C, defined as HCV-RNA above the lower detection limit of analytical methods) or chronic hepatitis requiring antiviral therapy;
• Participants who have previously received or are preparing to receive allogeneic bone marrow transplantation or solid organ transplantation;

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (1)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Pheochromocytoma

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Paraganglioma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Shengjie Guo, Doctor

  Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Fangjian Zhou, Doctor

CONTACT

13922735659; zhoufj@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sun Yat-sen University Cancer Center

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: May 28, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 28, 2027
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

CN (1)