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Intrahepatic Cholangiocarcinoma clinical trials

View clinical trials related to Intrahepatic Cholangiocarcinoma.

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NCT ID: NCT06375915 Recruiting - Clinical trials for Intrahepatic Cholangiocarcinoma

Precision Medicine in Patients With Unresectable CholAngiocarcinoma: RadioEmbolization and Combined Biological Therapy

PM-CARE
Start date: May 1, 2024
Phase: Phase 2
Study type: Interventional

Underlying disease mechanisms are fundamental for correct treatment selection and patient management in highly invasive and debilitating non-transmissible diseases. Even though overall disease burden of cancer may have decreased due to a higher degree of awareness, the availability of high-quality healthcare and early diagnosis may become challenging in certain neoplasms. Cholangiocarcinoma is usually diagnosed at advanced stages due to non-specific presentation and is frequently refractory to chemotherapy, causing a massive impact on patients and their families. Surgery is currently the only curative treatment but is available to only approximately 30% of patients. The combination of interventional- and immune-oncology to standard of care creates the perfect substrate for synergistic mechanisms to fight tumor growth; in situ cell death following transarterial embolization(TARE) elicits immune mediated response, inflammatory response and biomarkers of oxidative stress and increases antigen presenting T-cells which an anti-anti progam death ligand (PD-L)1 can bind to; standard of care can then add on with its known effects.The rationale of a combined- locoregional and systemic - treatment lies in the synergistic effects of each of the treatments.

NCT ID: NCT06370663 Recruiting - Clinical trials for Intrahepatic Cholangiocarcinoma

First-line Treatment for Unresectable Locally Advanced Distal Cholangiocarcinoma Combining Radiotherapy and HAIC

Start date: April 1, 2024
Phase: Phase 2
Study type: Interventional

The median survival of intrahepatic cholangiocarcinoma remains less than one year, highlighting the need for new treatments. Hepatic arterial infusion chemotherapy (HAIC), especially with fluoropyrimidine-based regimens, has shown promise in ICC treatment due to increased local drug concentration and reduced systemic toxicity. A combined approach of radiotherapy and HAIC with gemcitabine infusion may offer a hopeful strategy for locally advanced cholangiocarcinoma. However, clinical research on this combination is lacking as first-line therapy for unresectable ICC. Therefore, a single-center, single-arm study aims to assess this treatment approach's safety, efficacy, and molecular predictors. Improved HAIC delivery through modified percutaneous implantation provides a reliable pathway for effective treatment. In conclusion, exploring the synergistic effects of radiotherapy and HAIC in ICC could pave the way for more effective and personalized treatment strategies for this challenging cancer type.

NCT ID: NCT06342414 Recruiting - Clinical trials for Hepatocellular Carcinoma

An Exosome-Based Liquid Biopsy for the Differential Diagnosis of Primary Liver Cancer

ELUCIDATE
Start date: March 15, 2024
Phase:
Study type: Observational

It is sometimes difficult to precisely understand whether a primary liver cancer is a hepatocellular carcinoma or a cholangiocarcinoma. The researchers will develop and validate a liquid biopsy, based on exosomal content analysis and powered by machine learning, to help clinicians differentiate these two cancers before surgery.

NCT ID: NCT06335927 Recruiting - Clinical trials for Intrahepatic Cholangiocarcinoma

HAIC Combined With Cadonilimab and Regorafenib as 2nd-line Treatment for ICC

Start date: May 11, 2023
Phase: Phase 2
Study type: Interventional

This study is a single-arm Phase II clinical trial aiming to evaluate the safety and efficacy of HAIC combined with Cadonilimab and Regorafenib as second-line treatment for unresectable intrahepatic cholangiocarcinoma. The study plans to enroll approximately 45 participants. All enrolled participants will receive continuous treatment: HAIC-Gemox: Gemcitabine 1000mg/m2 on Day 1 + Oxaliplatin 85mg/m2 on Day 1, every 3 weeks (Q3W), for up to 6 treatment cycles, Cadonilimab(6mg/kg, D2, Q3W) and Regorafenib (80mg QD, Q3W) until the investigator determines that there is no longer any clinical benefit (based on comprehensive assessment including RECIST v1.1 imaging evaluation and clinical condition), intolerable toxicity, initiation of new anti-tumor therapy, or meeting other criteria for treatment discontinuation, whichever occurs first.

NCT ID: NCT06313203 Recruiting - Chemotherapy Effect Clinical Trials

HAI-Floxuridine, or SIRT, Combined With Gemox For Patients With Intra-Hepatic Cholangiocarcinoma Not Amenable to Resection (TOMCAT)

TOMCAT
Start date: February 13, 2024
Phase: Phase 2
Study type: Interventional

Patients with intrahepatic cholangiocarcinoma (IHC) have relatively aggressive tumors, and the prognosis for most of these patients is dismal. Surgery is the only option that can offer potential cure, but only an estimated 20-25 % are amenable to resection. Down-staging conventional chemotherapy has a relatively low response rate (< 50 %). Patients will be included into the respective treatment arms based on their tumour characteristics and disease stage, but also based on their ability/preferences, as HAI-FUDR/DEX requires going to Oslo every fortnight for the duration of the treatment and SIRT has some limitations regarding tumour distribution. Data from the MSKCC has suggested a clinically relevant benefit from adding intrahepatic chemotherapy to systemic therapy. HAI-FUDR/DEX is not approved in Norway and can only be evaluated in a protocolized trial. Given the risk of distant disease progression with IHC, the addition of conventional systemic chemotherapy makes good clinical sense, and data from MSKCC supports this approach. SIRT is another modality also applied trans-arterially and directly into the tumour. This treatment is approved in Norway and available in Bergen and in Oslo. It is far less cumbersome to deliver and maintain than HAI-FUDR/DEX. The efficacy and safety of the two treatment groups, HAI-FUDR/DEX and SIRT, will be compared in a parallel cohort (non-randomized) design

NCT ID: NCT06298968 Recruiting - Clinical trials for Intrahepatic Cholangiocarcinoma

Combined Therapy Using Gemcitabine and Cisplatin Chemotherapy, Lenvatinib and Adebrelimab for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma

Start date: February 25, 2024
Phase: Phase 2
Study type: Interventional

In this phase 2 study, the investigators aim to evaluate the efficacy and safety of combined therapy using gemcitabine and cisplatin chemotherapy, Lenvatinib and Adebrelimab for patients with advanced and unresectable intrahepatic cholangiocarcinoma

NCT ID: NCT06296563 Recruiting - Clinical trials for Intrahepatic Cholangiocarcinoma

Perioperative Treatment of Resectable Intrahepatic Cholangiocarcinoma With the Combination of Adebrelimab and Apatinib and HAIC

Start date: March 1, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to explore the efficacy and safety of combined infusion chemotherapy with Adebrelimab and Apatinib in the perioperative treatment of resectable intrahepatic cholangiocarcinoma patients. The main question it aims to answer are: How to improve the survival of patients with intrahepatic cholangiocarcinoma and prolong the recurrence time after surgery. Participants will receive receive neoadjuvant therapy with Adebrelimab combined with apatinib and FOLFOX-HAIC for 2 cycles (1 treatment cycle every 21 days, apatinib only used for the first cycle), and surgery was performed 14-28 days after the end of treatment. After 28 days of surgery, patients will continue to receive adjuvant treatment with Adebrelimab combined with apatinib for a maximum of one year.

NCT ID: NCT06290739 Recruiting - Clinical trials for Intrahepatic Cholangiocarcinoma

A Machine-learning Model to Predict Lymph Node Metastasis of Intrahepatic Cholangiocarcinoma

Start date: February 7, 2024
Phase:
Study type: Observational

The object of this study is to develop a model for prediction of lymph node metastasis among intrahepatic cholangiocarcinoma (ICC) patients. Intrahepatic cholangiocarcinoma is the second most common kind of primary liver cancer, accounting for approximately 10%-15%. There is a lack of agreement regarding the necessity of performing lymph node dissection (LND) in patients with ICC. Currently, the percentage of LND is below 50%, and the rate of sufficient LND (≥6) has plummeted to less than 20%. Consequently, a large proportion of patients are unable to acquire LN status, which hinders the following systematic treatment strategies after surgery:. Therefore, our objective is to construct a LN metastasis model utilizing machine learning techniques, including patients' clinical data and pathology information, with the goal of offering a reference for patients who have not undergone LND or have had inadequate LND.

NCT ID: NCT06239532 Recruiting - Clinical trials for Intrahepatic Cholangiocarcinoma

HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma

Start date: September 27, 2022
Phase: Phase 2
Study type: Interventional

This is a single center, single arm, phase II, prospective study to evaluate the safety and effectiveness of HAIC combined with TAE plus an ICI and an TKI in adult patients (aged ≥18 years) with unresectable intrahepatic cholangiocarcinoma.

NCT ID: NCT06208462 Recruiting - Clinical trials for Intrahepatic Cholangiocarcinoma

Neoadjuvant Therapy of HAIC(GEMOX) Combined With Adebrelimab and Lenvatinib for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors

Start date: March 25, 2024
Phase: Phase 2
Study type: Interventional

Clinical Study on the efficacy and safety of HAIC(GEMOX)and Lenvatinib combined with Adebrelimab neoadjuvant therapy for resectable Intrahepatic Cholangiocarcinoma with high-risk recurrence factors.