EUCTR2017-004679-29-FR
Active, not recruiting
Phase 1
Immunotherapy in neoadjuvant and adjuvant setting in patients with advanced HCC treated by electroporation in curative intent: French multicenter phase 2 therapeutic trial - NIVOLEP
Conditionsivolumab in neoadjuvant and adjuvant setting in patients with advanced HCC treated by electroporationMedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsOpdivo
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ivolumab in neoadjuvant and adjuvant setting in patients with advanced HCC treated by electroporation
- Sponsor
- ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female patients superior or equal 18 years
- •\-Histological or cytological documentation of HCC or non\-invasive diagnosis of HCC as per American Association for the Study of Liver Diseases (AASLD) criteria in patients with a confirmed diagnosis of cirrhosis
- •\-Barcelona Clinical Liver Cancer (BCLC) stage Category B or C
- •\-Patients with HCC amenable for EP as assessed by multidisciplinary board corresponding to the following extension:
- •oUninodular HCC \>3cm and \<5cm
- •oMultinodular HCC
- •\-At least one uni\-dimensional measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to modified RECIST for HCC
- •\-Liver function status Child\-Pugh Class A
- •\-Eastern Cooperative Oncology Group (ECOG) Performance Status inferior or equal 2
- •\-Adequate bone marrow, liver and renal function as assessed by the following laboratory tests:
Exclusion Criteria
- •Patients with past history of HCC
- •\-Patients with contraindications to EP
- •\-Patients with contraindication to contrast medium intravenous injection either gadolinium or iodinate
- •\-Prior liver transplantation or candidates for liver transplantation
- •\-Prior systemic treatment for HCC
- •\- Patients with autoimmune disease and patients requiring chronic systemic treatment with corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications.
- •\-Patients with large esophageal varices at risk of bleeding that are not being treated with conventional medical intervention
- •\-Past or concurrent history of neoplasm other than HCC, except for in situ carcinoma of the cervix uteri and/or non\-melanoma skin cancer and superficial bladder tumors. Any cancer curatively treated \> 3 years prior to study entry is permitted
- •\-Known history or symptomatic metastatic brain or meningeal tumors
- •\-Major surgical procedure or significant traumatic injury within 28 days before enrolment
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Phase 1
Gastric cancer immunotherapyIRCT20170208032451N1Mashhad University of Medical Sciences5
Recruiting
Phase 2
A Study of Neoadjuvant Therapy for the Treatment of Patients With Locally Advanced Esophageal Squamous Cell CarcinomaNeoadjuvant TherapyEsophageal Squamous Cell CarcinomaNCT06354530Army Medical Center of PLA266
Active, not recruiting
Not Applicable
a Neo-adjuvant Chemotherapy Immunotherapy in Resectable ESCC StudyThe Neoadjuvant Treatment for Resectable Esophageal Squamous Cell CarcinomaNCT06472635Zhejiang University95
Active, not recruiting
Phase 1
Safety and Efficacy of Neoadjuvant immunotherapy with Durvalumab (MEDI 4736) in combination with neoadjuvant chemotherapy (Gemcitabin/Cisplatin or Gemcitabin/Carboplatin) in patients with operable, high-risk, localized urothelial carcinoma of the upper urinary tract.The patient has a histologically-confirmed (ureteroscopic biopsy) or cytologically(urine cytology)-confirmed diagnosis of high-grade urothelial carcinoma of the renal pelvis or ureter. Presence of divergent histologies (i.e. squamous-cell tumor, adenocarcinoma, small cell carcinoma, micropapillary variant) may be acceptable provided that there is an important prevalence (> 90%) of urothelial component.MedDRA version: 20.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2020-001028-32-FRCHU DE NIMES99
Recruiting
Not Applicable
Neoadjuvant Immunotherapy of Operable Metastatic Melanoma in Real Life (GCC)Melanoma MetastaticNCT06586593Centre Hospitalier Universitaire de Besancon77