A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia

A Randomized, Multi-Center, Double-Blind, Phase III Study Evaluating the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia

The study is being conducted to evaluate the efficacy, and safety of of Hetrombopag Olamine Tablets Vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia.

Study Overview

• Status: Recruiting
• Conditions: Patients With Chemotherapy-Induced Thrombocytopenia
• Intervention / Treatment: Drug: Hetrombopag Olamine; Drug: Hetrombopag Olamine ；Hetrombopag Olamine Placebo

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Junye Xiong; Phone Number: 0518-82342973; Email: junye.xiong@hengrui.com

Study Locations

• United States
  • California
    • Los Alamitos, California, United States, 90254
      • Not yet recruiting
      • Cancer and Blood Specialty Clinic
      • Principal Investigator: Arati Chand
  • Colorado
    • Denver, Colorado, United States, 80210
      • Not yet recruiting
      • AdventHealth Hematology and Oncology Denver Cypress Hematology and Oncology
      • Principal Investigator: Yousuf Gaffar
  • Florida
    • Coral Springs, Florida, United States, 33065
      • Not yet recruiting
      • Oncology & Hematology Associates of West Broward
      • Principal Investigator: Sumit Sawhney
    • Orange City, Florida, United States, 32763
      • Recruiting
      • Mid-Florida Hematology & Oncology Centers, P.A.
      • Principal Investigator: Santosh Nair
  • Illinois
    • Springfield, Illinois, United States, 62702
      • Not yet recruiting
      • Springfield Clinic
      • Principal Investigator: Preet Singh
  • New Jersey
    • Morristown, New Jersey, United States, 07039
      • Not yet recruiting
      • Morristown Medical Center
      • Principal Investigator: Se young Han
  • New York
    • Shirley, New York, United States, 11967
      • Not yet recruiting
      • New York Cancer and Blood Specialists One Oncology
      • Principal Investigator: Richard Zuniga

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female gender, age ≥18 years at screening.
2. Histologically or cytologically confirmed solid tumor (e.g., non-small-cell lung carcinoma [NSCLC], breast, ovarian, bladder, pancreatic, gastrointestinal, or colon/colorectal cancer).
3. Receiving platinum- and/or gemcitabine-containing chemotherapy regimens on 21-day treatment cycles.
4. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
5. Life expectancy ≥6 months.
6. Signed ICF for voluntary participation in the study and good compliance.

Exclusion Criteria:

1. Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia).
2. Hematologic malignancies.
3. Thrombocytopenia caused by reasons other than chemotherapy, including but not limited to chronic liver disease, hypersplenism, infection, and hemorrhage, within 6 months prior to Study Day 1.
4. Untreated brain metastases; or with leptomeningeal metastasis.
5. Conditions that require emergent treatment (e.g., superior vena cava syndrome, spinal cord compression).
6. Severe cardiovascular disorders or interventions within 6 months
7. Have arterial/venous thrombosis within 6 months
8. Known bleeding disorders, platelet dysfunction
9. Severe haemorrhage during screening
10. Acute or uncontrolled hepatitis B&C infection
11. Human immunodeficiency virus (HIV) infection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: Hetrombopag Olamine	Drug: Hetrombopag Olamine; For Part A, all participants would receive hetrombopag treatment.
Experimental: Part B：Hetrombopag Olamine vs Hetrombopag Olamine Placebo	Drug: Hetrombopag Olamine ；Hetrombopag Olamine Placebo; For Part B，participants would be randomized to receive hetrombopag treatment or matching placebo, respectively。

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part A: Cmax of hetrombopag in non-Asian participants with CIT, around 6 months.	around 6 months.
Part A: AUC0-tauof hetrombopag in non-Asian participants with CIT, around 6 months	around 6 months
Part A: Cmin of hetrombopag in non-Asian participants with CIT, around 6 months	around 6 months
Part B:A platelet count of ≥100×109/L within 14 days after initiating the investigational product treatment, around 3 years	around 3 years
Part B:No use of any rescue therapy for thrombocytopenia during the treatment period from the initiation of investigational product treatment until Cycle 2 Day 21, around 3 years.	around 3 years.
Part B:Complete two consecutive on-study chemotherapy cycles (Cycle 1 and Cycle 2) without thrombocytopenia-induced modification of any myelosuppressive agent, around 3 years;	around 3 years;

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants achieving platelet count ≥100×109/L without the use of rescue therapy within 14 days after initiating the investigational product treatment,around 3 years;	around 3 years;
platelet count nadir from Cycle 1 Day 1 until Cycle 2 Day 21, around 3 years;	around 3 years;
Proportion of participants free from serious bleeding events, during the treatment period from the initiation of IP treatment until C2D21, around 3 years;	around 3 years;
Proportion of participants with neutropenia during the treatment period from the initiation of IP treatment until Cycle 2 Day 21, around 3 years.	around 3 years.
Number of Adverse Events/Serious Adverse Events, safety lab parameters, vital signs, etc within study period, around 3 years.	around 3 years.

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: SHR8735-303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No