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Prospective clinical study of Jiawei Buzhong Yiqi Decoction combined with CRT in the treatment of unresectable locally advanced esophageal squamous cell carcinoma

Prospective clinical study of Jiawei Buzhong Yiqi Decoction combined with CRT in the treatment of unresectable locally advanced esophageal squamous cell carcinoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000465
Enrollment
Unknown
Registered
2025-03-05
Start date
2024-06-22
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

esophagus cancer

Interventions

control group:Treatment with simple CRT regimen a total of 6 cycles during which no other drugs with the same effect were used. Appropriate nutritional support and symptomatic treatment can be given
experimental group:Jiawei Buzhong Yiqi Decoction combined with CRT regimen was given for a total of 6 cycles No other drugs with the same effect can be used and corresponding nutritional support and s

Sponsors

Suining Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Locally advanced recurrent or metastatic esophageal squamous cells that have been pathologically or cytologically proven to be inoperable cancer (i.e. esophageal squamous cell carcinoma). 2)18 years old =75 years old expected survival =3 months physical fitness score (ECOG PS) of 0 or 1 points. 3) The patient is fully informed in good compliance and voluntarily signs a written informed consent which must be performed at the same time treatment related procedures are signed before. 4) The clinical stage is ? to ? (according to The American Joint Committee on Cancer 8th edition) on Cancer 8th edition AJCC 8th]) patients who are inoperable (or the patient refuses to undergo surgery). 5) Locally advanced recurrent or metastatic esophageal squamous cells that have been pathologically or cytologically proven to be inoperable cancer. The histological type of the diagnosed esophageal cancer was squamous cell carcinoma. 6) Consent and be able to take the decoction. 7)The patient had at least one measurable lesion and was

Exclusion criteria

Exclusion criteria: 1) Adenocarcinoma adeno-squamous mixed type or other pathological types of esophageal cancer. 2) Patients with previous or combined history of other malignant tumors and other anti-tumor therapy. 3) Complicated with serious organic disease or infection mental patients and intellectual and language disorders pregnancy or preparation pregnant and lactating women. 4) Patients who cannot tolerate chemotherapy treatment and have chemotherapy contraindications. 5) The expected survival time is less than 3 months can not take the decoction there is a taboo to take Chinese medicine. 6) Incomplete clinical data.

Design outcomes

Primary

MeasureTime frame
Overall SurvivalOS;progression free survival PFS;

Secondary

MeasureTime frame
disease control rate DCR;objective response rate ORR;duration of response DoR;

Countries

China

Contacts

Public ContactNa Li

Suining Central Hospital

1500921245@qq.com19911866118

Outcome results

None listed

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