Clinical trial NCT06080880: Ondanstron Weekly vs Every 3 Weeks for Prevention of Nausea and Vomiting Induced by Chemotherapy Combined With PD-1 Blockade
Official title: Ondanstron Weekly vs Every 3 Weeks for Prevention of Nausea and Vomiting Induced by Chemotherapy Combined With PD-1 Blockade：an Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nausea With Vomiting Chemotherapy-Induced
Keywords: Chemotherapy-induced nausea and vomiting
PD-1 blockade
Ondanstron
Lead sponsor: Hubei Cancer Hospital
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: PREVENTION

Brief summary: The aim of this randomized study is to compare the efficacy and safety of ondanstron weekly with every 3 weeks for the prevention of nausea and vomiting induced by chemotherapy combined with PD-1 blockade.

Detailed description: Nausea and vomiting have become the most common and intolerant adverse events in patients receiving chemotherapy, which cause substantial impairments in human functions and quality of life. In some serious cases, patients refused further treatment and lead to disruption of the course of treatment.

For highly emetogenic chemotherapy(HEC), a standard triple therapy including 5-hydroxytryptamine-3 receptor antagonist(5-HT3RA), neurokinin-1 receptor antagonist(NK-1RA) plus corticosteriod. Recently, a few trials have achieved success in reduction of post-discharge application of corticosteriod based on the standard triple therapy, which offered new insights to update the current therapeutic regimens.

Although the emetogenicity of PD-1 blockade seems to be slighter than HEC, previous studies have reported gastrointestinal immune-related adverse events(GI-IrAE) in patients treated with PD-1 blockade, of which 55% of the participants suffered nausea and vomiting. Noteworthy, recently researchers highlight the importance of prevention and control of nausea more than that of vomiting in terms with chemotherapy-induced nausea and vomiting.

Therefore, the investigators initiated this study to compare the efficacy and safety of ondanstron weekly with every 3 weeks for the prevention of nausea and vomiting induced by chemotherapy combined with PD-1 blockade, which may provide new insights for fully prevention and control compare the efficacy and safety of ondanstron weekly with every 3 weeks for the prevention of nausea and vomiting induced by chemotherapy combined with PD-1 blockade in aimed population.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years, no gender limit;
2. Pathologically or cytologically confirmed malignant solid tumors;
3. Scheduled to receive cisplatin-based chemotherapy combined with PD-1 blockade；
4. TPS \> 1 %(PD-1);
5. Adequate hematological function (leucocyte count ≥ 4000/μL \[to convert to ×109/L,multiply by 0.001\], hemoglobin ≥ 9.00 g/dL \[to convert to grams per liter, multiply by 10\], and platelet count ≥ 100 × 103/μL \[to convert to ×109/L, multiply by 1\]);
6. Hepatic function (alanine aminotransferase and aspartate aminotransferase ≤ 2.0 times the upper limit of the reference ranges), and renal function (creatinine clearance ≥ 60 mL/min/1.73 m2 \[to convert to millimeters per second per meter-squared, multiply by 0.0167\])；
7. Estimated survival time \> 6 months；
8. ECOG 0-1 points；
9. Participants being informed and signed written consents.

Exclusion Criteria:

1. Nausea or vomiting caused by reasons except for chemotherapy and PD-1 blockade;
2. Participants with other malignant tumors history previously;
3. Inability to read, comprehend, and finish questionnaires;
4. Allergic to the drugs included in this study.
5. Administered drugs with antiemetic activity within the 24 hours before receiving the first dose of study medication.

Primary outcomes:
measure: Complete response(CR) rate
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: The proportion of patients with sustained no emesis, sustained no nausea, sustained no significant nausea, and the mean time to first emetic episode.
timeFrame: Assessed every week
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
Study officials:
affiliation: Hubei Cancer Hospital, Wuhan, HuBei, China, 430079
name: Guang Han, MD
role: PRINCIPAL_INVESTIGATOR
References: