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Anlotinib Plus Penpulimab (AK105) for Chemo-refractory Metastatic Colorectal Cancer:ALTER-C003 (ALTER-C003)

6 de marzo de 2022 actualizado por: YueJuan Cheng, Peking Union Medical College Hospital

Anlotinib Hydrochloride In Combination With Penpulimab (AK105) in Patients With Chemo-refractory Metastatic Colorectal Cancer, Open, Single Arm,Exploratory Clinical Trial(ALTER-C003)

A single-arm, open-label clinical trial, focus on the safety and efficacy of anlotinib hydrochloride in combination with Penpulimab (AK105) in patients with Chemo-refractory Metastatic Colorectal Cancer (mCRC)

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

32

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Jianfeng Zhou
  • Número de teléfono: 011-86-10-69156114
  • Correo electrónico: ZhouJF@pumch.cn

Ubicaciones de estudio

  • Porcelana
      • Beijing, Porcelana
        • Reclutamiento
        • Peking Union Medical College Hospital
        • Contacto:
      • Shenyang, Porcelana
        • Aún no reclutando
        • The First Hospital of China Medical University
        • Contacto:
          • Xiujuan Qu
      • Shenyang, Porcelana
        • Aún no reclutando
        • The People's Hospital of Liaoning Province
        • Contacto:
          • Du Zhenguang
    • Beijing
      • Beijing, Beijing, Porcelana
        • Reclutamiento
        • Beijing Tiantan Hospital, Capital Medical University
        • Contacto:
          • Xiaoyuan Li
        • Investigador principal:
          • Xiaoyuan Li
      • Beijing, Beijing, Porcelana
        • Aún no reclutando
        • China-Japan Friendship Hospital
        • Investigador principal:
          • Yuan Li
        • Contacto:
          • Yuan Li
    • Hebei
      • Langfang, Hebei, Porcelana
        • Aún no reclutando
        • Hebei Petro China Central Hospital
        • Contacto:
          • Qian Guo
        • Investigador principal:
          • Qian Guo
      • Shijiazhuang, Hebei, Porcelana
        • Aún no reclutando
        • The Fourth Hospital of Hebei Medical University (Hebei Cancer Hospital)
        • Investigador principal:
          • Ruixing Zhang
        • Contacto:
          • Ruixing Zhang
          • Número de teléfono: 0086-311-86095757
    • Tianjin
      • Tianjin, Tianjin, Porcelana
        • Reclutamiento
        • General Hospital of Tianjin Medical University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Patients participate in the study voluntarily and sign informed consent with good compliance.
  • Be 18 years of age or older on day of signing informed consent.
  • Histological or cytological confirmation of Metastatic Colorectal Cancer(T1-4N0-2M1).
  • At least one measurable lesion, with diameter ≥ 10mm measured by spiral MRI/CT scan per RECIST1.1.
  • Participants must have received and progressed through or become intolerant to fluoropyrimidine, irinotecan, oxaliplatin, Exceptions may apply.
  • Eastern Cooperative Oncology Group Performance Status 0 or 1.
  • Life expectancy of at least 3 months.
  • Main organs function is normal. (normal main organs function as defined below: Hemoglobin (Hb) ≥ 90 g/L, Neutrophils (ANC) ≥ 1.5×109/L, leucocyte (WBC) ≥ 3.0×109/L,Platelet count (PLT) ≥ 75×109/L,Total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN), Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 ×ULN, If liver metastasis is present，ALT and AST<5ULN ；Serum creatinine (Cr) ≤ 1.5× ULN or Creatinine Clearance rate(CCr) ≥60ml/min，Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) > 50%)
  • The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 3 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 8 weeks after it.

Exclusion Criteria:

  • Histological or cytological confirmation of mucinous adenocarcinoma or ovarian transcoelomic metastasis
  • Patients who had previously received treatment with Anlotinib or anti-programmed cell death protein 1 (PD-1), programmed cell death protein 1 ligand 1 (PD-L1), or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors other immunotherapy against .
  • Patients who had previously received treatment within 2 weeks or Participated in other anti-tumor clinical trials within 4 weeks.
  • Patients with a large amount of pleural effusion or ascites requiring drainage.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
  • Patients who underwent major surgery within 4 weeks.
  • Regardless of the severity, patients with any physical signs or history of bleeding, patients with bleeding or bleeding events greater than or equal to CTCAE 3 within four weeks prior to the first administration, or patients with unhealed wounds, fractures, ulcers.
  • Patients with a risk of gastrointestinal bleeding may not be enrolled.
  • Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism.
  • Patients with any severe and/or unable to control diseases，including： Patients with unsatisfactory blood pressure control using antihypertensive drugs (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100) mmHg); Patients with Grade 2 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including male QTc≥450ms; female QTc≥470ms) and patients with Grade 2 or higher congestive heart failure (NYHA Classification); Patients with active or unable to control serious infections, which is over level 2 in CTC AE (4.0); Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L); Patients with kidney failure who require hemodialysis or peritoneal dialysis; Patients with interstitial lung disease with symptoms or signs of activity；Patients with a history of immunodeficiency, including a positive HIV test or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; Urine routine indicates that urine protein ≥ ++, and confirmed 24-hour urine protein quantitation > 1.0 g; Patients with any of the following coagulation functions are abnormal, including: Prothrombin time (PT)>ULN+4s, Activated partial thromboplastin time (APTT) >1.5ULN s, international normalized ratio (INR)>1.5; Patients with a seizure disorder who require pharmacotherapy.
  • Patients who have got non remissive toxic reactions derived from any treatment, which is over level 1 in CTC AE (4.0).
  • Has a diagnosis of immunodeficiency or is receiving chronic steroid therapy of prednisone ≥ 10 mg daily or any equivalent dose of corticosteroids.
  • Has received a live vaccine or attenuated vaccine within 30 days prior to trial registration.
  • Symptoms that affect oral medication and cannot be controlled through proper treatment (such as inability to swallow, chronic diarrhoea and intestinal obstruction, etc.).
  • Female patients who are pregnant or breastfeeding.
  • Patients with drug abuse history and unable to get rid of or patients with mental disorders.
  • Patients who had serious adverse effect to Anlotinib or Penpulimab or any of its excipients
  • Known hypersensitivity to other Monoclonal Antibody or any of its excipients.
  • Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Anlotinib+Penpulimab
Droga: Penpulimab
Penpulimab 200 mg por vía intravenosa cada 3 semanas.
Otros nombres:
  • AK105
Droga: Anlotinib
12 mg, suspensión oral continua de 2 semanas durante 1 semana, 21 días para un ciclo de tratamiento.
Otros nombres:
  • clorhidrato de anlotinib

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression-free survival (PFS)
Periodo de tiempo: up to 24 months
Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
up to 24 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Tasa de Control de Enfermedades (DCR)
Periodo de tiempo: hasta 24 meses
La tasa de control de la enfermedad se define como el porcentaje de sujetos cuya mejor respuesta fue RC, PR o enfermedad estable (SD) según RECIST v1.1.
hasta 24 meses
Objective Response Rate (ORR)
Periodo de tiempo: up to 24 months
Objective response rate is defined as the percentage of subjects whose best response was complete response (CR) or partial response (PR) according to the RECIST v1.1
up to 24 months
Duration of Response (DOR)
Periodo de tiempo: up to 24 months
Duration of Response is defined as the percentage of subjects whose best response was CR, PR or stable disease (SD) according to the RECIST v1.1 or death due to any cause, whichever occurs first.
up to 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Periodo de tiempo: Until 30 day safety follow-up visit
Adverse events assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).
Until 30 day safety follow-up visit
Overall Survival (OS)
Periodo de tiempo: Up to 24 months
Overall Survival (OS) (median) is determined using the number of months measured from the initial date of treatment to the recorded date of death of participants.
Up to 24 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of TB cells count and interleukin-6/8/10
Periodo de tiempo: through study completion, an average of 2 year
Objectives to analyse the subsets of TB cells and interleukin-6/8/10 associated treatment.
through study completion, an average of 2 year

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Peking Union Medical College Hospital

Investigadores

  • Investigador principal: Jianfeng Zhou, Peking Union Medical College Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

5 de noviembre de 2021

Finalización primaria (Anticipado)

23 de agosto de 2022

Finalización del estudio (Anticipado)

23 de agosto de 2023

Fechas de registro del estudio

Enviado por primera vez

5 de julio de 2021

Primero enviado que cumplió con los criterios de control de calidad

13 de julio de 2021

Publicado por primera vez (Actual)

21 de julio de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de marzo de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

6 de marzo de 2022

Última verificación

1 de marzo de 2022

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HS-2986B

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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