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New treatment option for Intrahepatic Cholangiocarcinoma (Icc)
Official title A Prospective Phase II Study of Postoperative Concurrent Chemoradiotherapy in Patients With Intrahepatic Cholangiocarcinoma
ClinicalTrials.gov ID: NCT07063888
What this study is testing
- What it's testing
- This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant concurrent chemoradiotherapy with simultaneous integrated boost following hepatectomy for intrahepatic cholangiocarcinoma with narrow margin (\<1cm) or nodal involvement. Eligibility patients will receive IMRT or VMAT.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age \> 18 years, \< 80 years
- Patients with primary surgical treatment
- Postoperative pathology confirmed intrahepatic cholangiocarcinoma
- Postoperative pathology showing narrow resection margin (\<1cm) or positive lymph nodes
- R0/R1 resection
You likely can't join if
- History of malignancies, except for basal cell skin carcinoma and in situ carcinoma of the cervix
- Had prior abdominal irradiation
- Had prior liver transplantation
- Had serious myocardial disease or renal failure
- Had moderate or severe ascites with obvious symptoms 4 months after surgery
- Duration from surgery ≥ 4 months
See the full eligibility criteria
- Age \> 18 years, \< 80 years
- Patients with primary surgical treatment
- Postoperative pathology confirmed intrahepatic cholangiocarcinoma
- Postoperative pathology showing narrow resection margin (\<1cm) or positive lymph nodes
- R0/R1 resection
- Postoperative Child-Pugh score A5-B7
- Patients meeting either of the following conditions must undergo preoperative or pre-radiotherapy PET-CT to exclude distant metastasis or lymph node metastasis beyond the region from the lower esophagus to the aortic...
- Lymph node metastasis accounting for \>50% of dissected nodes
- Lymph node metastasis involving the paracardial region or below the renal vein level
- Postoperative contrast-enhanced liver MRI to exclude Intrahepatic satellite nodules
- Recovery from surgery with Eastern Cooperative Oncology Group performance status score of 0-2
- Estimated life expectancy \>3 months
- History of malignancies, except for basal cell skin carcinoma and in situ carcinoma of the cervix
- Had prior abdominal irradiation
- Had prior liver transplantation
- Had serious myocardial disease or renal failure
- Had moderate or severe ascites with obvious symptoms 4 months after surgery
- Duration from surgery ≥ 4 months
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.