Prospective Study Evaluating Efficacy and Safety of Olanzapine and Aprepitant for Cisplatin-induced Nausea and Vomiting in Hepatic Arterial Infusion Chemotherapy for Hepatocellular Carcinoma

Prospective Study Evaluating Efficacy and Safety of Olanzapine and Aprepitant for Cisplatin-induced Nausea and Vomiting in Hepatic Arterial Infusion Chemotherapy for Hepatocellular Carcinoma - PROACT study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000042360

Enrollment

Registered

2020-11-05

Start date

2020-11-05

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Hepatocellular carcinoma

Interventions

&lt

Initial treatment(1)&gt

Granisetron (GRA) 3mg, just before treatment Olanzapine (OLA) 5mg, in the morning on day 1 and before bedtime on day 1-4 &lt

Initial treatment(2)&gt

GRA 3mg, just before treatment &lt

Second treatment(1)&gt

In addition to initial treatment, aprepitant (APR) 125mg, in the morning on day 1 APR 80mg, in the morning on day 2, 3 &lt

Second treatment(2)&gt

Same as initial treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) 20 years old or more 2) diagnosed of HCC according to the JSH guideline (2017) 3) CDDP-HAIC planned within 7 days 4) no prior HAIC within 3 months 5) informed consent obtained

Exclusion criteria

Exclusion criteria: 1) pregnant, possibly pregnant or breastfeeding 2) regular use of olanzapine or other antipsychotic drugs 3) previous participation in this study 4) moderate or severe (NRS 4 or more) nausea 5) considered not appropriate for participating in this study

Design outcomes

Primary

Measure	Time frame
Complete response (CR) rate within 120 hours in patients treated with olanzapine	—

Secondary

Measure	Time frame
1) CR rate, complete control (CC) rate and total control (TC) rate within 24 hours 2) CR rate, CC rate and TC rate within 24-120 hours 3) Numerical rating scale scores of nausea, vomiting and anorexia on day 1-6 4) Frequency of vomiting within 120 hours 5) Frequency of rescue antiemetic treatment within 120 hours 6) Frequency, severity and timing of adverse events due to antiemetic treatment 7) Child-Pugh score and ALBI score at 2 weeks and 1 month after treatment	—

Measure

Time frame

1) CR rate, complete control (CC) rate and total control (TC) rate within 24 hours 2) CR rate, CC rate and TC rate within 24-120 hours 3) Numerical rating scale scores of nausea, vomiting and anorexia on day 1-6 4) Frequency of vomiting within 120 hours 5) Frequency of rescue antiemetic treatment within 120 hours 6) Frequency, severity and timing of adverse events due to antiemetic treatment 7) Child-Pugh score and ALBI score at 2 weeks and 1 month after treatment

—

Countries

Japan

Contacts

Public ContactMasayuki Ueno

Kurashiki Central Hospital Department of Gastroenterology and Hepatology

mu13951@kchnet.or.jp0864220210

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026