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Postoperative concurrent chemoradiotherapy for preventing recurrence of intrahepatic cholangiocarcinoma: a prospective randomized controlled trial

Postoperative concurrent chemoradiotherapy for preventing recurrence of intrahepatic cholangiocarcinoma: a prospective randomized controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030411
Enrollment
Unknown
Registered
2020-03-01
Start date
2020-03-15
Completion date
Unknown
Last updated
2020-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrahepatic cholangiocarcinoma

Interventions

Sponsors

Cancer Hospital of Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. With primary intrahepatic cholangiocarcinoma; 2. Aged <= 70 years, no serious complications of circulation, respiratory or metabolic system; 3. Child-pugh grade A for preoperative liver function;ICG-R15 <10%; 4. Confirmed by preoperative imaging examination and intraoperative exploration: single lesion, no intrahepatic /extrahepatic metastasis, no portal vein or hepatic vein trunk or primary branch cancer plug; 5. R0 resection confirmed by postoperative pathological examination; 6. One of the following is confirmed by postoperative pathological examination: (1) Reach or exceed stage IB by stages (With any situation following: large/microvascular invasion, satellite nodules, positive lymph nodes, liver capsule invasion, tumour size? 5 cm ). (2) Tumour margin ?1cm; (3) Low differentiation.

Exclusion criteria

Exclusion criteria: 1. Patients with cognitive impairment cannot sign the informed consent independently; 2. With malignant tumors of other organs or systems; 3. Patients who received other major organ resection (except gallbladder) at the same time; 4. Patients do not receive radiotherapy, or have radiotherapy contraindications; 5. With severe abdominal infection, postoperative intestinal fistula, biliary fistula, etc.; 6. Other circumstances in which the investigator considers that it is inappropriate for the patient to participate in the trial.

Design outcomes

Primary

MeasureTime frame
RFS;

Secondary

MeasureTime frame
OS;Recurrence Pattern;

Countries

China

Contacts

Public ContactLiming Wang

Cancer Hospital of Chinese Academy of Medical Sciences

stewen_wang@sina.com+86 18911597091

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026