NCT07063888 A Prospective Phase II Study of Postoperative Concurrent Chemoradiotherapy in Patients With Intrahepatic Cholangiocarcinoma
| NCT ID | NCT07063888 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Intrahepatic Cholangiocarcinoma (Icc) |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2025-05-16 |
| Primary Completion | 2028-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 66 participants in total. It began in 2025-05-16 with a primary completion date of 2028-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. The prescription dose to high-risk area of tumor bed or positive lymph node was planned at 55-60Gy and the prescription dose to lymphatic drainage regions was planned at 40-45Gy in 20-25 fractions. During radiotherapy, patients will concurrently receive capecitabine (1600 mg/m² on days 1-14, every 21 days for 2 cycles). After radiotherapy, maintenance therapy with capecitabine will continue (2000 mg/m² on days 1-14, every 21 days for 6 cycles). For patients who cannot tolerate capecitabine, S-1 will be used as an alternative. The primary endpoint is 2-year recurrence-free survival. The secondary endpoints are 2-year overall survival, local-regional control rate and incidence of grade 3 or higher adverse events.
Eligibility Criteria
Inclusion 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 bifurcation 1. Lymph node metastasis accounting for \>50% of dissected nodes 2. 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07063888 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Intrahepatic Cholangiocarcinoma (Icc). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07063888 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07063888 currently recruiting?
Yes, NCT07063888 is actively recruiting participants. Contact the research team at chenboo@outlook.com for enrollment information.
Where is the NCT07063888 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07063888 clinical trial?
NCT07063888 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 66 participants.