2024-518065-10-00招募中2 期
A Randomized Phase II Study of Systemic Chemotherapy with or without HAI FUDR/Dexamethasone in Patients with Unresectable Intrahepatic Cholangiocarcinoma
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
Compare the progression-free survival (PFS) of HAI FUDR/Dex in combination with systemic GemOx versus systemic GemOx only.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •Platelet count ≥ 75,000/mcL
- •Creatinine ≤ 1.8 mg/dL
- •Total bilirubin < 1.5 mg/dL
- •Hgb > 7 g/dL
- •Histologically confirmed intrahepatic cholangiocarcinoma (also variously reported as peripheral cholangiocarcinoma, cholangiolar carcinoma or cholangiocellular carcinoma) (IHC). Confirmation of the diagnosis at MSKCC or at the enrolling institution must be obtained prior XML File Identifier: OlvDuYrPr+P0rcY9vFJaMIbUhz8= Page 23/33 to randomization.
- •Clinical or radiographic evidence of metastatic disease confined to the liver. Note: presence of regional (porta hepatis) lymph node metastases will be allowed, provided they are amenable to resection. (Note: If peritoneal or other extrahepatic disease is found at time of pump placement, the pump will not be implanted. The patient will be removed from study, deemed nonevaluable and will not count toward the overall study accrual.)
- •Radiographically measurable disease. Measurable disease is defined as disease that can be assessed with 2-dimensional measurements on a cross-sectional imaging. Minimum lesion size is 2 cm in greatest diameter as per RECIST criteria
- •Disease must be considered unresectable at the time of preoperative evaluation.
- •Considered candidate for general anesthesia, abdominal exploration and hepatic artery pump placement
- •Patients with chronic hepatitis and/or cirrhosis are eligible, but must be Child-Pugh class A.
- •WBC ≥ 2,000/mcL , ANC ≥ 1000/mcL
排除标准
- •Presence of distant metastatic disease. Patients will undergo radiographic evaluation to exclude the possibility of distant metastatic disease. For patients who have undergone pre- or post-operative biopsies that definitively diagnose IHC, the diagnostic studies may be modified at the discretion of the MSKCC Principal Investigator. Clinical or radiographic evidence of metastatic disease to regional lymph nodes will be allowed, provided it is amenable to resection
- •History of other malignancy within the past 3 years except with early stage/localized cancer that was surgically resected or radiation treatment that would yield the same result as surgery within the past 3 years.
- •Life expectancy <12 weeks
- •Inability to comply with study and/or follow-up procedures.
- •History of peripheral neuropathy.
- •Patients previously treated with systemic chemotherapy for IHC will be non-eligible.
- •Prior treatment with FUDR.
- •Prior external beam radiation therapy to the liver.
- •Prior ablative therapy to the liver.
- •Diagnosis of sclerosing cholangitis
- •Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis; surgically related ascites does not exclude the patient).
- •Active infection within one week prior to HAI placement.
- •Pregnant or lactating women.
研究组 & 干预措施
-
Experimental
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Progression-free survival
Progression-free survival
次要结局
- 1. Compare the overall survival in first-line HAI FUDR/Dex in combination with GemOx versus systemic GemOx only.
- 2. Estimate the overall response rate (CR+PR) between treatment groups.
- 3. Estimate the time to first recurrence patterns between treatment groups.
- 4. Describe the toxicity rates separately for each treatment groups.
- Define the mutational pattern of IHC and determine the extent to which genomic features and intratumoral heterogeneity correlate with treatment response and survival.
研究者
Andrea Cercek
Scientific
Memorial Sloan Kettering Cancer Center
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
A Phase II Study to Evaluate the Efficacy and Safety of Anti-HER2 Triple-targeted Drugs Combined With CDK4/6 Inhibitors in Neoadjuvant Therapy for ER-positive HER2-positive Breast Cancer Patients.Breast CancerNCT07290166Fudan University42
已完成
3 期
A Study Evaluating the Safety and Efficacy of Polatuzumab Vedotin in Combination with Rituximab Plus Gemcitabine Plus Oxaliplatin (R- GEMOX) Versus R- GEMOX Alone in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma2024-512537-33-00F. Hoffmann-La Roche AG49
招募中
3 期
PRODIGE 98- AMPIRINOX : Randomized, multicenter, Phase III trial of adjuvant chemotherapy with modified FOLFIRINOX versus capecitabine or gemcitabine in patients with resected ampullary adenocarcinoma.2024-511070-68-01Centre Hospitalier Universitaire De Dijon294
招募中
2 期
Phase 2 Trial to determine the safety and efficacy of simultaneous treatment with ruxolitinib and extracorporeal photopheresis for patients with steroid-refractory chronic Graft-versus-Host-Disease (SR-cGvHD) - RUX-ECP2023-507754-33-00Medical Center - University Of Freiburg40
招募中
1 期
A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D MutationNCT07259590Genfleet Therapeutics (Shanghai) Inc.126