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A multicenter, open-label, phase IIB clinical study protocol comparing Huoxiang Zhengqi Oral Liquid with olanzapine quadruple-combination regimen for the prevention of CINV caused by 3-day cisplatin hyperemetic combined chemotherapy

A multicenter, open-label, phase IIB clinical study protocol comparing Huoxiang Zhengqi Oral Liquid with olanzapine quadruple-combination regimen for the prevention of CINV caused by 3-day cisplatin hyperemetic combined chemotherapy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104728
Enrollment
Unknown
Registered
2025-06-23
Start date
2025-06-23
Completion date
Unknown
Last updated
2025-06-30

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

Conditions

Tumor

Interventions

treatment group:Administer 5-HT3RA+NK-1RA+ dexamethasone + Huoxiang Zhengqi Oral Liquid. Take one tablet of NEPA (Netopitan 300mg/ Palonosetron 0.5mg) orally 60 minutes before administration on the fi
control group:A quadruple antiemetic regimen (5-HT3RA+NK-1RA+ olanzapine + dexamethasone) was given. Take one tablet of NEPA (Netopitan 300mg/ Palonosetron 0.5mg) orally 60 minutes before administrati

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Age: 18 to 75 years old (including the boundary value); (2) Patients who meet the diagnostic criteria for malignant tumors in Western medicine and have solid tumors; (3) It conforms to the TCM syndrome differentiation criteria for internal injury and dampness stagnation syndrome; (4) Those who have received chemotherapy for the first time (those who have received adjuvant chemotherapy before can be enrolled, but it must be more than 6 months since the end of the last chemotherapy), and the chemotherapy regimen is HEC containing 3-day cisplatin (combination with albumin-paclitaxel, pemetrexed, etoboside, gemcitabine, vinorelbine, 5-fluorouracil, bevacizumab, Endu, ICIs is allowed); (5) The General Physical Condition (ECOG) score is between 0 and 2 points; (6) The patient has good compliance and can take Huoxiang Zhengqi Oral Liquid smoothly. (7) The hematological, liver and kidney function, cardiac function and important organ function indicators meet the requirements of chemotherapy; (8) Cooperate to complete the chemotherapy plan, agree to participate in this clinical trial, and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) There are uncontrolled intracranial metastatic lesions; (2) Accompanied by uncontrolled and stable cancer pain; (3) Those with a history of chronic nausea and vomiting, or those with concurrent acute/chronic digestive tract diseases that cause nausea and vomiting; (4) Nausea and vomiting of any cause within the past 3 days; (5) Radiotherapy, TKI targeted therapy and interventional therapy (embolization, chemotherapy perfusion, particle implantation) are planned to be carried out during the study period; (6) The use of antiemetic agents, herbal medicines with potential antiemetic components, benzodiazepines or opioid preparations (except for triazolam, temazepam or midazolam taken once daily) and other drugs that have an impact on the results of this study within 48 hours before enrollment; (7) Those who are known or suspected of being allergic to the ingredients of the drug used or have an allergic constitution; (8) Other circumstances where the researcher deems it inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
NCDs;

Secondary

MeasureTime frame
CINV-CR;NNDs;CIN-CR;Incidence of CINV;Life function;Degree of drowsiness;Degree of fatigue;Quality of life;

Countries

China

Contacts

Public ContactZhu Jiang

West China Hospital, Sichuan University

zhujiang@wchscu.cn+86 189 8060 2256

Outcome results

None listed

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