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Intrahepatic Cholangiocarcinoma clinical trials

View clinical trials related to Intrahepatic Cholangiocarcinoma.

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NCT ID: NCT06417606 Not yet recruiting - Clinical trials for Intrahepatic Cholangiocarcinoma

Lenvatinib and Adebrelimab Combined With GEMOX in the Perioperative Treatment of Potentially Resectable Intrahepatic Cholangiocarcinoma

Start date: May 30, 2024
Phase: Phase 4
Study type: Interventional

A single-arm, prospective clinical study was conducted to enroll 20 subjects. Each subject was treated with oral Lenvatinib + Adebrelimab + GEMOX (gemcitabine + oxaliplatin). The treatment phase before surgery was 3 cycles, and the evaluation was performed every 2 cycles. The evaluation was repeated before surgery, and the decision of surgery was made according to the evaluation results. To evaluate the efficacy and safety of Lenvatinib and Adebrelimab combined with GEMOX in the perioperative treatment of potentially resectable intrahepatic cholangiocarcinoma.

NCT ID: NCT06406816 Not yet recruiting - Clinical trials for Intrahepatic Cholangiocarcinoma

Neoantigen Vaccine Plus Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma After Radical Resection

Start date: May 2024
Phase: Early Phase 1
Study type: Interventional

This study is a single-arm, open-label, exploratory clinical trial, with the primary objective to evaluate the efficacy and safety of the Neoantigen Vaccine plus capecitabine for the treatment of high-intermediate risk recurrent intrahepatic cholangiocarcinoma

NCT ID: NCT06375642 Not yet recruiting - Clinical trials for Intrahepatic Cholangiocarcinoma

A Single Arm, Single Centered Phase II Trial on the Combination of Adebrelimab, Surufatinib and Irinotecan Liposome-based HAIC in Advanced iCC

Start date: May 10, 2024
Phase: Phase 2
Study type: Interventional

Southeast Asia and China have the highest incidence of intrahepatic cholangiocarcinoma worldwide, with limited treatment options and large unmet medical needs. Hepatic arterial infusion chemotherapy (HAIC) has gradually emerged as a promising treatment option for patients with hepatocellular carcinoma (HCC). Increasing evidence suggests that infusion of HAIC, which maintains high local concentrations of toxic agents in tumors without embolism, provides a significant survival benefit for patients with advanced HCC and is well-tolerated. However, there is limited evidence for the efficacy of HAIC for intrahepatic cholangiocarcinoma. Irinotecan liposome (nal-IRI) is a concentrate of an infusion solution containing 5 mg/ml irinotecan trihydrate (irinotecan sucrose salt) active substance, which is encapsulated in liposomes and prevents premature conversion of the drug to SN-38 in the liver. Liposomal irinotecan prolongs the circulation time of the drug in the plasma of patients and prolongs the tumor exposure of the drug compared to conventional irinotecan.Nal-IRI based protocol has shown positive results in the phase III trial of pancreatic carcinoma. Adebrelima(SHR-1316) is a recombinant humanized IgG4 antibody that binds efficiently and specifically to human and cynomolgus programmed cell death ligand 1 (PD-L1, CD274, or B7-H1), a cell surface molecule that plays an important role in T cell immune function, and stimulates IFN-γ secretion from mixed lymphocyte reactions (MLRs) of dendritic cells (DCs) and CD4 + T cells. Surufatinib is a multiple kinase inhibitor targeting VEGFR 1-3, FGFR1 and CSF1R. This study aims to evaluate the efficacy and safety of irinotecan liposome-based hepatic arterial infusion chemotherapy combined with adebrelimab and surufatinib in the treatment of intrahepatic cholangiocarcinoma, which may bring significant clinical benefit to the iCC patients with new treatment options.

NCT ID: NCT06313554 Not yet recruiting - Clinical trials for Intrahepatic Cholangiocarcinoma

Surufatinib Combined With Toripalimab and HAIC in the Treatment of Inoperable or Metastatic Intrahepatic Cholangiocarcinoma

Start date: May 20, 2024
Phase: N/A
Study type: Interventional

This study is a single-arm, open-arm, single-center clinical study to explore the efficacy and safety of HAIC in combination with Surufatinib and Toripalimab in patients with inoperable or metastatic intrahepatic cholangiocarcinoma. The study was divided into three stages: screening period, treatment period and follow-up period. During the treatment period, the tumor status was evaluated by imaging every 6 weeks (±7 days), and the efficacy was changed to every 8 weeks (±7 days) after 12 weeks until the disease progressed (RECIST 1.1) or death (during the treatment of the patient) or toxicity became intolerable. The tumor treatment status and survival status after the disease progression were recorded. Safety outcome measures included AE, changes in laboratory test values, vital signs and electrocardiogram changes.

NCT ID: NCT06134193 Not yet recruiting - Carcinoma Clinical Trials

Combination Therapy of HAIC, Surufatinib and Tislelizumab for Unresectable or Metastatic Biliary Tract Cancer

Start date: November 2023
Phase: Phase 2
Study type: Interventional

This is a single-arm, exploratory study to evaluate the efficacy and safety of HAIC in combination with surufatinib and tislelizumab in the first line treatment of patients with unresectable or metastatic biliary tract cancer

NCT ID: NCT05896956 Not yet recruiting - Gallbladder Cancer Clinical Trials

The Construction of Clinical Database and Multiomics Biobank Based on a Multicentral Prospective Cohort of Benign and Malignant Biliary Tract Diseases

Start date: July 1, 2023
Phase:
Study type: Observational [Patient Registry]

The aim of the study is to establishing a standardized biobank and a clinical information database for patients with benign and malignant tumors of the biliary system. With follow-up plans and advanced multiomics technology, a multiomics database for patients with benign and malignant tumors of the biliary tract will be further established. Based on the above work, real-world clinical research on the diagnosis and treatment of biliary tract tumors is about to be carried out, and a high-standard cohort research foundation is laid for precision therapy based on multiomics characteristics and molecular typing of biliary tract tumors.

NCT ID: NCT05681949 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Therapeutic Assistance and Decision-making Algorithms in Hepatobiliary Tumor Boards

ADBoard
Start date: November 2023
Phase: N/A
Study type: Interventional

The goal of this observational study is to compare the recommendations of the artificial intelligence clinical decision support system 'ADBoard', with the recommendations of physicians by tumor conferences in patients with hepatobiliary tumors. The main questions it aims to answer are: Can ADBoard achieve a high level of similar recommendations as physicians' tumor conferences? Can ADBoard consider a more complete set of patient-related data than in physicians' tumor conferences? Can ADBoard reduce the time between the first time the patient is discussed at the tumor conference and the start of the recommended treatment plan? Participants will have their hepatobiliary tumor treatments determined by either tumor conference with ADBoard, or tumor conference without ADBoard.

NCT ID: NCT05644743 Not yet recruiting - Clinical trials for Intrahepatic Cholangiocarcinoma

Clinical Transformation of Organoid Model to Predict the Efficacy of GC in the Treatment of Intrahepatic Cholangiocarcinoma

Start date: January 2023
Phase:
Study type: Observational

The clinical incidence of intrahepatic cholangiocarcinoma (ICC) is high and insidious, and the prognosis of advanced patients is poor. The clinical manifestations of traditional chemotherapy GC and emerging targeted therapy are different in most patients, and there is still no effective scheme to evaluate the differences in individual patient reactivity. Patient-derived tumor organoids (PDO) are 3D-cultured tissues based on tumor cell dryness that reproduce a variety of biological characteristics of parental tumors in vitro and have similar drug responsiveness to tumors in vivo. This project plans to use clinical cases and optimized organoid culture system to first construct relevant organoids from unresectable ICC patient puncture samples. Secondly, based on the organoid model of intrahepatic cholangiocarcinoma, the clinical efficacy of GC regimen was predicted, and in vitro and in vivo drug screening was conducted to explore the guidance of patient-derived tumor organoids for clinical treatment. Then, multi-omics data of organoids and in vitro and in vivo drug efficacy evaluation model were used to explore the drug resistance genes of intrahepatic cholangiocarcinoma, providing the basis for personalized drug screening and efficacy evaluation of intrahepatic cholangiocarcinoma.

NCT ID: NCT05535647 Not yet recruiting - Clinical trials for Intrahepatic Cholangiocarcinoma

Second Line Therapy for Advanced Intrahepatic Cholangiocarcinoma

Start date: September 25, 2022
Phase: Phase 2
Study type: Interventional

This is a prospective, Two-arm, comparative, randomized, controlled phase II trial, to explore the efficacy and safety of Regorafenib and HAIC vs. FOLFOX as Second Line Therapy for Advanced Intrahepatic Cholangiocarcinoma.

NCT ID: NCT05422690 Not yet recruiting - Clinical trials for Intrahepatic Cholangiocarcinoma

The Purpose of This Research Study is to See if Combining Gemcitabine, Cisplatin and Durvalumab Chemotherapy Treatments With a Direct Tumor Therapy Yittrium-90 (Y-90) Will Work Better Together to Shrink Tumors and Control Cancer

Start date: May 15, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this research is to see if combining gemcitabine, cisplatin and Durvalumab chemotherapy treatments with a direct tumor therapy called Yittrium-90, will work better together to shrink the tumor and control cancer.