Efficacy and Safety of Chidamide+Sintilimab+Bev as Second-Line Therapy in Advanced Extrapulmonary Neuroendocrine Carcinoma

NCT07518602 | Recruiting Phase 2

• 1 other identifier: CAPability-06
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, multicenter phase Ⅱ study to evaluate the therapeutic efficacy and safety of chidamide + sintilimab + bevacizumab in subjects with advanced extrapulmonary neuroendocrine carcinoma who have failed first-line standard therapy. The primary purpose is to assess the objective response rate (ORR) of chidamide + sintilimab + bevacizumab in the above-mentioned subjects, with a planned enrollment of 34 subjects with advanced extrapulmonary neuroendocrine carcinoma who have failed first-line standard therapy.

Conditions

Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)

Keywords

extrapulmonary neuroendocrine carcinoma; chidamide; sintilimab; bevacizumab

Outcome Measures

Primary Outcomes (1)

• ORR

  The primary endpoint of this study is the objective response rate (ORR) of chidamide + sintilimab + bevacizumab in the enrolled subjects, defined as the proportion of subjects achieving complete response (CR) or partial response (PR) evaluated by the investigator based on RECIST v1.1.

  From date of first study treatment until disease progression, up to approximately 37 months.

Secondary Outcomes (5)

• PFS

  From date of first study treatment until disease progression, up to approximately 37 months.

• OS

  From date of first study treatment until disease progression, up to approximately 37 months.

• DCR

  From date of first study treatment until disease progression, up to approximately 37 months.

• DOR

  From date of first study treatment until disease progression, up to approximately 37 months.

• Incidence of Adverse Events (AEs)

  From date of first study treatment until disease progression, up to approximately 37 months.

Study Arms (1)

CAP

EXPERIMENTAL

chidamide + sintilimab + bevacizumab

Drug: Chidamide; Drug: Sintilimab; Drug: Bevacizumab

Interventions

Chidamide DRUG

20 mg of chidamide administered orally twice a week (BIW) 30 minutes after meals

CAP

Bevacizumab DRUG

7.5 mg/kg of bevacizumab administered via intravenous drip once every 3 weeks (Q3W)

CAP

Sintilimab DRUG

200 mg of sintilimab administered via intravenous drip once every 3 weeks (Q3W)

CAP

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed locally advanced, unresectable, or metastatic extrapulmonary neuroendocrine carcinoma (NEC).
• Failure of first-line standard systemic therapy, with documented disease progression during or after treatment by imaging or clinical evidence (e.g., cytology of new ascites or pleural effusion). Patients who discontinued first-line therapy due to intolerable toxicity are eligible.
• At least one measurable lesion per RECIST version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Able to provide written informed consent and comply with study visits and procedures.
• Age ≥ 18 years and ≤ 75 years.
• Life expectancy ≥ 12 weeks.
• Women of childbearing potential and men with female partners of childbearing potential must use effective contraception throughout the treatment period and for 6 months after the last dose of study treatment.
• Adequate organ and bone marrow function within 7 days before enrollment, without support treatments (blood products, growth factors, albumin) within 14 days before testing: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; platelet count (PLT) ≥ 100 × 10⁹/L; hemoglobin (HGB) ≥ 9.0 g/dL; serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); ALT/AST ≤ 3.0 × ULN (no liver metastasis) or ≤ 5.0 × ULN (with liver metastasis); serum albumin ≥ 25 g/L; serum creatinine (Cr) ≤ 1.5 × ULN; urine protein \< 2+ or 24-hour urine protein \< 1 g if urine protein ≥ 2+; INR ≤ 1.5 × ULN and APTT ≤ 1.5 × ULN.

You may not qualify if:

• Prior exposure to any anti-angiogenic therapy or histone deacetylase (HDAC) inhibitor.
• Received any investigational drug within 4 weeks before the first dose of study treatment.
• Simultaneously participating in another interventional clinical study (observational or follow-up studies are allowed).
• Received last dose of anti-tumor therapy (chemotherapy, targeted therapy, immunotherapy, embolization, etc.) within 3 weeks before first dose.
• Received radiotherapy within 4 weeks before first dose.
• Residual radiation-related toxicity (e.g., pneumonitis, hepatitis, enteritis) from prior radiotherapy \> 4 weeks before first dose, including symptomatic cases or those requiring corticosteroids.
• Received systemic immunosuppressive drugs within 4 weeks before first dose, except topical/inhaled corticosteroids or physiological systemic corticosteroids (≤ 10 mg/day prednisone equivalent).
• Received or plans to receive live attenuated vaccines within 4 weeks before first dose or during the study.
• Underwent major surgery within 4 weeks before first dose, or has unhealed wounds, ulcers, or fractures.
• Resolved toxicity from prior anti-tumor therapy not recovered to NCI CTCAE version 5.0 grade ≤ 1 (except alopecia or non-clinically significant laboratory abnormalities).
• Known symptomatic central nervous system (CNS) metastases or carcinomatous meningitis. Patients with treated and stable CNS metastases for ≥ 4 weeks and neurological symptoms recovered to grade ≤ 1 are allowed.
• Active autoimmune disease requiring systemic therapy within 2 years before first dose; or primary immunodeficiency. Replacement therapy (e.g., thyroid hormone, insulin) is permitted.
• Active tuberculosis, or anti-tuberculosis treatment within 1 year before first dose.
• Interstitial lung disease requiring corticosteroid treatment.
• Active hepatitis B (HBsAg positive and HBV DNA ≥ 200 IU/mL) or active hepatitis C (HCV antibody positive and HCV RNA positive).

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; sintilimab; Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Feng Wang, MD, PhD

  Sun Yat-sen Univesity Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Wang, MD, PhD

CONTACT

+86 020 87343795; wangfeng@sysucc.org.cn

Zhiqiang Wang, MD, PhD

CONTACT

+86 02087340776; wangzhq@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: Professor, Department Director

Model Details: chidamide + sintilimab + bevacizumab

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 8, 2026
• Study Start: March 27, 2026
• Primary Completion (Estimated): March 27, 2028
• Study Completion (Estimated): September 27, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)