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NCT07063888
A Prospective Phase II Study of Postoperative Concurrent Chemoradiotherapy in Patients With Intrahepatic Cholangiocarcinoma
Phase 2 trial testing Adjuvant Concurrent Chemoradiotherapy with Simultaneous Integrated Boost in Intrahepatic Cholangiocarcinoma (Icc) in 66 participants. Currently enrolling.
15 May 2028
Quick facts
| Lead sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 66 |
| Start date | 16 May 2025 |
| Primary completion | 15 May 2028 |
| Estimated completion | 15 May 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- Adjuvant Concurrent Chemoradiotherapy with Simultaneous Integrated Boost
Conditions studied
- Intrahepatic Cholangiocarcinoma (Icc) — all drugs for Intrahepatic Cholangiocarcinoma (Icc) →
- Adjuvant Chemoradiotherapy — all drugs for Adjuvant Chemoradiotherapy →
- Narrow Margin — all drugs for Narrow Margin →
- Lymph Node Involvement — all drugs for Lymph Node Involvement →
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Who can join
Adults 18 to 80, any sex, with Intrahepatic Cholangiocarcinoma (Icc) or Adjuvant Chemoradiotherapy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07063888
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07063888 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Last refreshed: 14 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07063888.
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