Patients With Chemotherapy-Induced ThrombocytopeniaPhase 3NCT07286032
A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia (ExCIT)
A Phase 3 study testing Hetrombopag Olamine in people with Patients With Chemotherapy-Induced Thrombocytopenia, run by Jiangsu HengRui Medicine Co., Ltd. at 51 sites in 11 countries.
Trial summary
The ExCIT study is being conducted to evaluate the efficacy, and safety of of Hetrombopag Olamine Tablets Vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Chemotherapy-Induced Thrombocytopenia
- What is being tested?
- Hetrombopag Olamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 51 sitesin 11 countries
- Study dates
- 16 Apr 2026to Jun 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age ≥ 18 years at screening.
- Histologically or cytologically confirmed solid tumor (e.g., non-small-cell lung carcinoma [NSCLC], breast, ovarian, bladder, pancreatic, gastrointestinal, or colon/colorectal cancer).
- Receiving platinum- and/or gemcitabine-containing chemotherapy regimens on 14- or 21-day treatment cycles.
- Platelet count < 85 x 109/L at enrollment.
- For Part B, experiencing a chemotherapy delay of ≥ 7 days due to CIT.
- At least 2 scheduled chemotherapy cycles of the same treatment regimen as was used prior to enrollment.
Show all 9Show fewer
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
- Life expectancy ≥6 months.
- Signed ICF for voluntary participation in the study and good compliance.
Who cannot join
- WHO Grade ≥ 2 bleeding within 14 days prior to screening.
- Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia).
- Hematologic malignancies.
- 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.
- Untreated brain metastases; or with leptomeningeal metastasis.
- Conditions that require emergent treatment (e.g., superior vena cava syndrome, spinal cord compression).
Show all 14Show fewer
- Severe cardiovascular disorders or interventions within 6 months.
- Have arterial/venous thrombosis with anticoagulation not tolerated for at least 6 weeks.
- Known bleeding disorders, platelet dysfunction.
- Severe haemorrhage during screening (e.g., gastrointestinal or intracranial hemorrhage) within 28 days prior to enrolment.
- Previous treatment with thrombopoietin receptor agonists (TPO-RAs) within 14 days prior to enrolment.
- Platelet transfusion within 72 hours prior to enrollment.
- Acute or uncontrolled hepatitis B\&C infection.
- Human immunodeficiency virus (HIV) infection.
Trial locations and contacts
51 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
51 sites in 11 countries
United States14 sites, 14 recruiting
- Recruiting
Clermont Oncology Center
Clermont, Florida, 34711
Gopal Kunta
Kunta Kunta
- Recruiting
Oncology & Hematology Associates of West Broward
Coral Springs, Florida, 33065
Sumit Sawhney
- Not yet recruiting
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, 39401
John Hrom
John Hrom
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Naomi Fei
Naomi Fei
- Recruiting
Cancer Partners of Nebraska
Lincoln, Nebraska, 68516
Irfan Vaziri
Irfan Vaziri
- Not yet recruiting
Starling Oncology
Long Beach, California, 90805
Omkar Marathe
Omkar Marathe
- Recruiting
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90254
Arati Chand
- Recruiting
UCLA
Los Angeles, California, 90095
Wanxing Chai-Ho
Wanxing Chai-Ho
- Not yet recruiting
Starling Oncology / Oncology Institute of Hope & Innovation
Miami, Florida, 33141
David Luis Sumoza
David Luis Sumoza
- Not yet recruiting
Morristown Medical Center
Morristown, New Jersey, 07039
Se young Han
- Not yet recruiting
MSK Cancer Center
New York, New York, 10065
Jodi Mones
Jodi Mones
- Recruiting
Mid-Florida Hematology & Oncology Centers, P.A.
Orange City, Florida, 32763
Santosh Nair
Santosh Nair
- Not yet recruiting
New York Cancer and Blood Specialists One Oncology
Shirley, New York, 11967
Richard Zuniga
- Recruiting
Springfield Clinic
Springfield, Illinois, 62702
Preet Singh
Spain8 sites, 8 recruiting
- Recruiting
Pratia ES Sirius Barcelona
Barcelona
Santiago Viteri Ramirez
Santiago Viteri Ramirez
- Not yet recruiting
Hospital Universitario Reina Sofía Córdoba
Córdoba
Elisabeth Inga Saavedra
Elisabeth Inga Saavedra
- Not yet recruiting
Hospital Universitari Arnau de Vilanova
Lleida
Salud Salvia Antonieta
Salud Salvia Antonieta
- Not yet recruiting
Hospital Universitario HM Madrid Sanchinarro
Madrid
Huertas Mondejar Helena
Huertas Mondejar Helena
- Not yet recruiting
Hospital Universitario Ramón y Cajal
Madrid
Belén de Frutos González
Belén de Frutos González
- Recruiting
Pratia ES Hospital Universitario de Torrejon
Madrid
Sara Custodio Cabello
Sara Custodio Cabello
- Not yet recruiting
Complejo Hospitalario Universitario de Orense
Ourense
Salgado Fernandez Mercedes
Salgado Fernandez Mercedes
- Not yet recruiting
Hospital Universitario General de Cataluña
Sant Cugat del Vallès
Xabier González Farré
Xabier González Farré
Turkey (Türkiye)8 sites, 8 recruiting
- Not yet recruiting
Istanbul Univ. Cerrahpasa Medical Faculty Hosp.
Fatih, Istanbul
Mustafa Ozguroglu
Mustafa Ozguroglu
- Not yet recruiting
I.E.U. Medicalpoint Izmir Hospital
Izmir
Cagatay Arslan
Cagatay Arslan
- Not yet recruiting
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Kadıköy, Istanbul
Mahmut Gümüş
Mahmut Gümüş
- Not yet recruiting
Pamukkale University Hospital
Kınıklı
Yuksel Urun
Yuksel Urun
- Not yet recruiting
Ankara Univ Cebeci Hospital Medical Oncology
Mamak, Ankara
Yuksel Urun
Yuksel Urun
- Not yet recruiting
Marmara University Pendik Training and Research Hospital
Pendik, Istanbul
Osman Kostek
Osman Kostek
- Not yet recruiting
Sakarya Univ. Training & Research Hosp. Oncology
Sakarya
Ilhan Hacibekiroglu
Ilhan Hacibekiroglu
- Not yet recruiting
Ankara Oncology TRH Clinical Research Center
Yenimahalle
Ayse Ocak Duran
Ayse Ocak Duran
Italy4 sites, 4 recruiting
- Not yet recruiting
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
Bari
Guida Michele
Guida Michele
- Not yet recruiting
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Milan
Sartore-Bianchi Andrea
Sartore-Bianchi Andrea
- Not yet recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
Antonuzzo Andrea
Antonuzzo Andrea
- Not yet recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia
Secondino Simona
Secondino Simona
China3 sites, 3 recruiting
- Not yet recruiting
Hong Kong United Oncology Centre
Hong Kong, Hong Kong, 000000
Yu Chung Li
Yu Chung Li
- Not yet recruiting
The Chinese University of Hong Kong
Hong Kong, Hong Kong, 000000
Herbert Long
Herbert Long
- Not yet recruiting
The University of Hong Kong
Hong Kong, Hong Kong, 000000
Rina Hui
Rina Hui
France3 sites, 3 recruiting
- Recruiting
Gustave Roussy Cancer Campus
Clémont
Florian Scotté
Florian Scotté
- Not yet recruiting
Centre Hospitalier Lyon Sud
Lyon
Freyer Gilles
Freyer Gilles
- Not yet recruiting
Groupe Hospitalier Pitie-Salpetriere
Paris
Abbar Baptiste
Abbar Baptiste
Romania3 sites, 3 recruiting
- Recruiting
Institutul Oncologic Bucuresti Prof Dr. Al. Trestioreanu with SC Arensia Exploratory Medicine
Bucharest
Laurentia Nicoleta Gales
Laurentia Nicoleta Gales
- Recruiting
Institute of Oncology "Ioan Chiricuta" Cluj-Napoca, Arensia Exploratory Medicine
Cluj-Napoca
Tudor Eliade Ciuleanu
Tudor Eliade Ciuleanu
- Not yet recruiting
Centrul de Oncologie Sfantul Nectarie Craiova
Craiova
Michael Schenker
Michael Schenker
South Korea3 sites, 3 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Eun Hee Jung
Eun Hee Jung
- Recruiting
Seoul National University Hospital
Seoul, 03080
Do-Youn Oh
Do-Youn Oh
- Not yet recruiting
Asan Medical Center
Seoul, 05505
Kyu-pyo Kim
Kyu-pyo Kim
Bulgaria2 sites, 2 recruiting
- Recruiting
ARENSIA Exploratory Medicine at "MBAL Sveta Sofia"
Sofia
Marchela Koleva, Dr.
Marchela Koleva, Dr.
- Not yet recruiting
UMHAT "Sv. Ivan Rilski", EAD
Sofia
Robev Bozhil
Robev Bozhil
Poland2 sites, 2 recruiting
- Not yet recruiting
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. ks. B. Markiewicza
Brzozów
Joanna Kiszka
Joanna Kiszka
- Not yet recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu, Klinika Onkologii
Poznan
Rodryg Ramlau
Rodryg Ramlau
Ukraine1 site, 1 recruiting
- Recruiting
ARENSIA Exploratory Medicine LLC
Kyiv
Myroslava Doronina
Myroslava Doronina
About this study
Official title: 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 ExCIT study is being conducted to evaluate the efficacy, and safety of of Hetrombopag Olamine Tablets Vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia.
- Being tested
- Hetrombopag Olamine, Hetrombopag Olamine; Hetrombopag Olamine Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hetrombopag OlamineDrug
For Part A, all participants would receive hetrombopag treatment.
Hetrombopag Olamine; Hetrombopag Olamine PlaceboDrug
For Part B, participants would be randomized to receive hetrombopag treatment or matching placebo, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Hetrombopag Olamine | Experimental | Not described Receives: Drug: Hetrombopag Olamine |
| Part B: Hetrombopag Olamine vs Hetrombopag Olamine Placebo | Experimental | Not described Receives: Drug: Hetrombopag Olamine; Hetrombopag Olamine Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Cmax of hetrombopag in non-Asian participants with CIT, around 6 months.
Measured: around 6 months.
Part A: AUC0-tauof hetrombopag in non-Asian participants with CIT, around 6 months.
Measured: around 6 months.
Part A: Cmin of hetrombopag in non-Asian participants with CIT, around 6 months.
Measured: around 6 months.
Part B: A platelet count of ≥100×109/L within 14 days after initiating the investigational product treatment, around 3 years.
Measured: 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 the end of the primary treatment period, around 3 years.
Measured: 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.
Measured: around 3 years.
Secondary outcomes (5)
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.
Measured: around 3 years.
Platelet count nadir from Cycle 1 Day 1 until the primary treatment period, around 3 years.
Measured: around 3 years.
Proportion of participants free from serious bleeding events, during the treatment period from the initiation of IP treatment until the primary treatment period, around 3 years.
Measured: around 3 years.
Proportion of participants with neutropenia during the treatment period from the initiation of IP treatment until the primary treatment period, around 3 years.
Measured: around 3 years.
Number of Adverse Events/Serious Adverse Events, safety lab parameters, vital signs, etc within study period, around 3 years.
Measured: around 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start16 Apr 2026
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Chemotherapy-Induced ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Part A should be completed firstly then move to Part B. Non-randomized for Part A, Randomized for Part B.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286032
- Sponsor's protocol ID
- SHR8735-303
- Status last verified
- Sep 2026
- First submitted
- 10 Dec 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided