Ondanstron Weekly vs Every 3 Weeks for Prevention of Nausea and Vomiting Induced by Chemotherapy Combined With PD-1 Blockade

NCT ID: NCT06080880

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2027-11-30

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.

Conditions

Nausea With Vomiting Chemotherapy-Induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Ondansetron every 3 weeks combined with aprepitant and dexamethasone

Group Type: EXPERIMENTAL

Ondansetron every 3 weeks

Intervention Type: DRUG

Ondansetron, Po, 24mg/d, 3 days' application every 3 weeks

Aprepitant

Intervention Type: DRUG

aprepitant, Po, 125mg/d, 1day' application every 3 weeks

Dexamethasone

Intervention Type: DRUG

dexamethasone, iv, 10mg/d, 1day' application every 3 weeks

Ondansetron weekly combined with aprepitant and dexamethasone

Group Type: EXPERIMENTAL

Aprepitant

Intervention Type: DRUG

aprepitant, Po, 125mg/d, 1day' application every 3 weeks

Dexamethasone

Intervention Type: DRUG

dexamethasone, iv, 10mg/d, 1day' application every 3 weeks

Ondansetron weekly

Intervention Type: DRUG

Ondansetron, Po, 24mg/d, 3 days' application weekly

Interventions

Ondansetron every 3 weeks

Ondansetron, Po, 24mg/d, 3 days' application every 3 weeks

Intervention Type: DRUG

Aprepitant

aprepitant, Po, 125mg/d, 1day' application every 3 weeks

Intervention Type: DRUG

Dexamethasone

dexamethasone, iv, 10mg/d, 1day' application every 3 weeks

Intervention Type: DRUG

Ondansetron weekly

Ondansetron, Po, 24mg/d, 3 days' application weekly

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hubei Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

HAN GUANG

Director of the department of Radiotherapy Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guang Han, MD

Role: PRINCIPAL_INVESTIGATOR

Hubei Cancer Hospital, Wuhan, HuBei, China, 430079

Locations

Hubei Cancer Hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Guang Han, MD

Role: CONTACT

hg7913@hotmail.com

13886048178

Facility Contacts

Han Guang, MD

Role: primary

Other Identifiers

2023-143-001

Identifier Type: -

Identifier Source: org_study_id