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AK112 Combination Therapy as First Line Treatment for Metastatic Digestive System Neuroendocrine Cancer

2026년 7월 14일 업데이트: Tianjin Medical University Cancer Institute and Hospital

A Prospective, Parallel, Double-cohort, Multicenter Phase II Clinical Study of Ivonescimab (AK112) Combined With IP Chemotherapy ± TACE for First-line Treatment of Metastatic Digestive System Neuroendocrine Cancer

This study is a single prospective, parallel, double-cohort, multicenter phase II clinical trial, aiming to evaluate the efficacy and safety of ivonescimab (AK112) combined with IP chemotherapy ± TACE in the first-line treatment of metastatic digestive system neuroendocrine cancer.

연구 개요

상태

아직 모집하지 않음

정황

신경내분비암

개입 / 치료

연구 유형

중재적

등록 (추정된)

단계

2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Rui Liu, Dr.
전화번호: 86+022-23340123
이메일: liurui9003@163.com

연구 장소

중국
- - Tianjin, 중국
    - Tianjin Medical University General Hospital
    - 연락하다:
      
      Qiong Qin
      
      전화번호: 86+13512203140
      
      이메일: qinqiong_@126.com
  - Tianjin, 중국
    - Tianjin Third Central Hospital
    - 연락하다:
      
      Hongsheng Guo
      
      전화번호: 86+18522107098
      
      이메일: uc999888@163.com
  - Tianjin, 중국
    - Tianjin Medical University Cancer Institute and Hospital
    - 연락하다:
      
      Rui Liu, Dr.
      
      전화번호: 86+022-23340123
      
      이메일: liurui9003@163.com
  - Tianjin, 중국
    - Tianjin First Central Hospital
    - 연락하다:
      
      Bing Ang
      
      전화번호: 86+16622108047
      
      이메일: able12ab@163.com
  - Tianjin, 중국
    - Tianjin People's Hospital
    - 연락하다:
      
      Hao Yan
      
      전화번호: 86+132 0760 3727
      
      이메일: sarahhao99@sina.cn
- Inner Mongolia
  - Baotou, Inner Mongolia, 중국
    - Baotou Cancer Hospital
    - 연락하다:
      
      Yunqi Hua
      
      전화번호: 86+13015056119
      
      이메일: hyqyfr@126.com
  - Tongliao, Inner Mongolia, 중국
    - The First People's Hospital of Horqin District, Tongliao City
    - 연락하다:
      
      Ning Chen
      
      전화번호: 86+13948556479
      
      이메일: 1599108551@qq.com
- Shanxi
  - Taiyuan, Shanxi, 중국
    - Shanxi Bethune Hospital
    - 연락하다:
      
      Yarong Guo
      
      전화번호: 86+13453410624
      
      이메일: gyr5258@126.com

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

성인
고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

Age: 18 - 75 years old;
Metastatic digestive system neuroendocrine carcinoma (NEC) confirmed by tissue or cytological examination;
For cohort 2 only: Liver metastasis, suitable for TACE;
No previous systemic treatment; For patients who received adjuvant therapy, disease recurrence and metastasis more than 6 months after the last treatment can be regarded as first-line treatment;
Clear measurable lesions meeting the requirements of RECIST (1.1); If the lesion that received previous local treatment (radiation, ablation, vascular intervention, etc.) is the only lesion, there must be clear imaging evidence of disease progression for this lesion;
ECOG score of 0 or 1;
Expected survival ≥ 12 weeks;
Basic normal functions of major organs and bone marrow;
Male or female patients with reproductive capacity voluntarily use effective contraceptive methods during the study period and within 6 months after the last study medication, such as double barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. All female patients will be considered to have reproductive capacity, unless the female patient has naturally menopause, artificial menopause or sterilization (such as hysterectomy, bilateral ovary removal or radiotherapy of the ovaries, etc.).
Have fully understood this study, voluntarily participated, and signed the informed consent form.

Exclusion Criteria:

Within the past 5 years, have been diagnosed with other malignant tumors (excluding carcinoma in situ, basal cell carcinoma, etc.);
Known to be allergic to any component of any study drug; have a history of severe hypersensitivity reaction to other monoclonal antibodies;
Within 4 weeks before enrollment, have received approved or investigational systemic anti-tumor treatment, including: photodynamic therapy, chemotherapy, radical radiotherapy, ablation, local radiotherapy (allowing for palliative radiotherapy for bone metastases at least 2 weeks before the study drug treatment), biological immunotherapy, targeted therapy, etc.;
Within 4 weeks before enrollment, have participated in other domestic clinical trials of drugs that have not been approved or are not yet on the market and have received corresponding trial drug treatment;
Within 4 weeks before enrollment, have received any surgery or invasive treatment or operation (except for intravenous catheterization, puncture drainage, etc.);
The patient currently has active ulcers in the stomach and duodenum, ulcerative colitis and other digestive tract diseases or active bleeding from the unresected tumor, or conditions that the investigator deems may cause gastrointestinal bleeding or perforation;
Within 3 months before enrollment, have obvious evidence or history of bleeding (more than 30 mL of bleeding within 3 months, hematemesis, black stool, bloody stool), hemoptysis (more than 5 mL of fresh blood within 4 weeks), or have had a thromboembolic event within 12 months (including stroke events and/or transient ischemic attacks);
Have significant clinical cardiovascular diseases, including but not limited to acute myocardial infarction within 6 months before enrollment, severe/unstable angina pectoris or coronary artery bypass surgery; New York Heart Association (NYHA) class > 2 for congestive heart failure; Drug treatment for ventricular arrhythmias; Electrocardiogram (ECG) showing QTc interval ≥ 480 milliseconds;
Unstable brain parenchymal metastases, spinal cord metastases or compression, cancerous meningitis or meningitis metastasis;
Have third space fluid that cannot be controlled by drainage methods (such as large amounts of ascites, pleural effusion, pericardial effusion, etc.), and the subjects need to control the third space fluid through drainage within 14 days before administration;
Active or uncontrolled severe infection (≥ CTCAE grade 2 infection);
Known human immunodeficiency virus (HIV) infection; Known significant liver disease history, including viral hepatitis [must exclude active HBV infection if the HBV DNA is positive (> 1×10^4 copies/mL or > 2000 IU/ml); known hepatitis C infection (HCV) and HCV RNA positive (> 1×10^3 copies/mL), or other hepatitis, liver cirrhosis];
Known mental illness, drug abuse, alcoholism or drug addiction history.
Pregnant or lactating women.
Have any disease, treatment, laboratory test abnormalities in the past or currently, which may confuse the research results, affect the full participation of the subjects in the research, or the participation in the research may not be in the best interests of the subjects.
Local or systemic diseases not caused by malignant tumors, or secondary diseases or symptoms of tumors, which may lead to higher medical risks and/or uncertainty in survival period evaluation, such as tumor leukemia reaction (white blood cell count > 20×109/L), cachexia manifestations (such as weight loss of more than 10% within 3 months before screening), etc.
Patients judged by the investigator to be unsuitable to participate in this study.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
할당: 무작위화되지 않음
중재 모델: 병렬 할당
마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔 참가자 그룹 / 팔 시험 프로토콜에 따라 특정 중재/치료를 받거나 중재를 받지 않는 임상 시험 참가자 그룹 또는 하위 그룹입니다.	개입 / 치료 개입 / 치료 임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.
실험적: NEC	의약품: AK112 Combination treatment period (4-6 cycles): AK112: 20mg/kg, intravenous infusion, administered on day 1, repeated every 3 weeks Maintenance treatment period: AK112: 20mg/kg, intravenous infusion, administered on day 1, repeated every 3 weeks 의약품: Irinotecan Combination treatment period (4-6 cycles): Irinotecan: 65 mg/m2, intravenous infusion, administered on days 1 and 8, repeated every 3 weeks 의약품: Cisplatin Combination treatment period (4-6 cycles): Cisplatin: 30 mg/m2, intravenous infusion, administered on days 1 and 8, repeated every 3 weeks
실험적: NEC with liver metastases	의약품: AK112 Combination treatment period (4-6 cycles): AK112: 20mg/kg, intravenous infusion, administered on day 1, repeated every 3 weeks Maintenance treatment period: AK112: 20mg/kg, intravenous infusion, administered on day 1, repeated every 3 weeks 의약품: Irinotecan Combination treatment period (4-6 cycles): Irinotecan: 65 mg/m2, intravenous infusion, administered on days 1 and 8, repeated every 3 weeks 의약품: Cisplatin Combination treatment period (4-6 cycles): Cisplatin: 30 mg/m2, intravenous infusion, administered on days 1 and 8, repeated every 3 weeks 절차: TACE Combination treatment period: TACE with epirubicin, 30-40 mg, every 3 weeks or every 6 weeks. The total treatment cycle is determined as needed.