Clinical study on the treatment of unresectable primary liver cancer with qi stagnation and blood stasis syndrome by Tanshinone Capsules combined with As2O3

Clinical study of tanshinone capsule combined with As2O3 in the treatment of unresectable primary liver cancer with Qi stagnation and blood stasis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2025001286

Enrollment

Unknown

Registered

2025-06-27

Start date

2025-07-01

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

liver cancer

Interventions

ATO study group:10mg arsenic trioxide +5-20ml iodide mixed infusion + embolic infusion. Oral placebo capsule 4 capsules 3 times a day

Combination group:10-20mg arsenic trioxide + iodide + embolic agent. Oral tanshinone capsule 4 capsules 3 times a day

Tanshinone Study Group:Epirubicin + iodide + embolic agent. Oral tanshinone capsule, 4 capsules, 3 times a day

control group:Epirubicin + iodide + embolic agent. Oral placebo capsule, 4 capsules, 3 times a day.

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients with unresectable CNLC stage ?b ?a and partial ?b primary liver cancer with detectable lesions (including postoperative recurrence or metastasis) with TCM syndrome of qi stagnation and blood stasis

Exclusion criteria

Exclusion criteria: Those with any of the following criteria were not included in the study (1) Patients with renal function injury (BUN greater than 3 times the upper limit of normal value) and those with obvious cardiac function injury. (2) There are obvious bad liquid quality. (3) Allergy or allergy to a variety of drugs or known allergy to As2O3 tanshinone preparations. (4) Pregnant or lactating women mental patients. (5) Patients who participated in other clinical studies within the last 1 month. (6) Patients who received radiotherapy or systemic chemotherapy within the last 1 month. ? There is a possibility of radiotherapy and systemic chemotherapy for patients during the study period. (8) The investigators believe that there are patients with unsuitable inclusion factors.

Design outcomes

Primary

Measure	Time frame
QLQ-HCC18 scale;QLQ-C30 Scale;Tumor lesion examination;	—

Secondary

Measure	Time frame
APF;TCM syndrome score;NRS pain score;Nutritional risk screening NRS2002;liver function;coagulation function;ecog;Karnofsky;ALB;Human APT;	—

Countries

China

Contacts

Public ContactSun Zhichao

the First Affiliated Hospital of Zhejiang Chinese Medical University

szcdcotor@163.com15988159028

Outcome results

None listed

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