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

NCT06080880 | Recruiting

• 1 other identifier: 2023-143-001
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea With Vomiting Chemotherapy-Induced

Keywords

Chemotherapy-induced nausea and vomiting; PD-1 blockade; Ondanstron

Outcome Measures

Primary Outcomes (1)

• Complete response(CR) rate

  Defined as no emesis and no rescue therapy

  Up to 6 weeks

Secondary Outcomes (1)

• The proportion of patients with sustained no emesis, sustained no nausea, sustained no significant nausea, and the mean time to first emetic episode.

  Assessed every week

Study Arms (2)

Ondansetron every 3 weeks combined with aprepitant and dexamethasone

EXPERIMENTAL

Drug: Ondansetron every 3 weeks; Drug: Aprepitant; Drug: Dexamethasone

Ondansetron weekly combined with aprepitant and dexamethasone

EXPERIMENTAL

Drug: Aprepitant; Drug: Dexamethasone; Drug: Ondansetron weekly

Interventions

Ondansetron every 3 weeks DRUG

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

Ondansetron every 3 weeks combined with aprepitant and dexamethasone

Aprepitant DRUG

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

Ondansetron every 3 weeks combined with aprepitant and dexamethasone; Ondansetron weekly combined with aprepitant and dexamethasone

Dexamethasone DRUG

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

Ondansetron every 3 weeks combined with aprepitant and dexamethasone; Ondansetron weekly combined with aprepitant and dexamethasone

Ondansetron weekly DRUG

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

Ondansetron weekly combined with aprepitant and dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years, no gender limit;
• Pathologically or cytologically confirmed malignant solid tumors;
• Scheduled to receive cisplatin-based chemotherapy combined with PD-1 blockade；
• TPS \> 1 %(PD-1);
• 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 \[to convert to ×109/L, multiply by 1\]);
• 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 \[to convert to millimeters per second per meter-squared, multiply by 0.0167\])；
• Estimated survival time \> 6 months；
• ECOG 0-1 points；
• Participants being informed and signed written consents.

You may not qualify if:

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

Sponsors & Collaborators

• Hubei Cancer Hospital: lead

Study Sites (1)

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

RECRUITING

MeSH Terms

Conditions

Vomiting

Interventions

Aprepitant; Dexamethasone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Guang Han, MD

  Hubei Cancer Hospital, Wuhan, HuBei, China, 430079

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guang Han, MD

CONTACT

13886048178; hg7913@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the department of Radiotherapy Oncology

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: October 12, 2023
• Study Start: December 1, 2023
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)