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The synergistic and attenuated mechanism of Xihuang pill in dual immunotherapy after stenting for advanced cholangiocarcinoma (PTIBS)

The synergistic and attenuated mechanism of Xihuang pill in dual immunotherapy after stenting for advanced cholangiocarcinoma (PTIBS)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076873
Enrollment
Unknown
Registered
2023-10-23
Start date
2023-11-30
Completion date
Unknown
Last updated
2023-10-30

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

Conditions

Cholangiocarcinoma

Interventions

Control group 1:Tumor Dual Immunotherapy Regimen (Tirilizumab Injection + Thymofaxine Injection). Tirilizumab Injection is administered by intravenous infusion at a recommended dose of 200 mg by intra
Control group 2:Only the tumor immunosuppressant (Tirilizumab injection) was administered. Tirilizumab Injection is administered by intravenous infusion at a recommended dose of 200 mg by intravenous
Observer group:Xihuang Pills combined with tumor double immunization ( Tirelizumab Injection + Thymalfasin Injection )
Xihuang Pills (Tongrentang Pharmaceuticals, Lot No. 20130619), 3g /times, 2 times/d, the course of treatment is 2 months. Xihuang Pills Usage and Dosage: Oral. 3g once, twice a day. Tirilizumab Inject

Sponsors

Affiliated Hospital of Jiangnan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 80 Years

Inclusion criteria

Inclusion criteria: ( 1 ) TNM stage IV ; ( 2 ) TCM syndrome differentiation is damp heat poly poison syndrome ; ( 3 ) The estimated survival time = 6 months ; ( 4 ) Meet the treatment indications, Karnofsky score = 60 points ; ( 5 ) The ethics committee passed, and the patients and their families signed the informed consent.

Exclusion criteria

Exclusion criteria: ( 1 ) Patients with severe heart, lung, liver, kidney and other organ diseases ; ( 2 ) Combined with other malignant tumors ; ( 3 ) Age 100µmol / L.

Design outcomes

Primary

MeasureTime frame
Coagulation function;Immune function;Tumor marker;

Countries

China

Contacts

Public ContactPeng Wang

Affiliated Hospital of Jiangnan University

xinglinxunbao@tom.com+86 187 6246 5649

Outcome results

None listed

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