Cervical Squamous Cell CarcinomaNCT07649395
A Prospective Study of the Early Treatment of Recombinant Human Thrombopoietin for Chemoradiation Induced Thrombocytopenia in Cervical Squamous Cell Carcinoma Patient
A study testing rhTPO in people with Cervical Squamous Cell Carcinoma, run by Mei Feng at 1 site in China.
Trial summary
To explore the early intervention timing of recombinant human thrombopoietin (rhTPO) for cancer treatment-induced thrombocytopenia (CTIT) in cervical squamous cell carcinoma (CSCC) patients during concurrent chemoradiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cervical Squamous Cell Carcinoma
- What is being tested?
- rhTPO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- KPS(Karnofsky Performance Status) >60 points;
- histopathologically or cytologically confirmed stage I-IVa CSCC (FIGO 2018); 3.18-70 years; receiving radical CCRT;
- 4.receiving rhTPO treatment when they occurred G1 or G2 CTIT at first presentation during CCRT; 5.expected survival time ≥6 months
Who cannot join
- patients with haematopoietic system diseases, including lymphoma, leukaemia, aplastic anaemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndromes;
- patients who had experienced non-CTIT within 6 months before screening, including but not limited to EDTA(Ethylenediaminetetraacetic acid)-dependent pseudothrombocytopenia, hypersplenism, infection, bleeding, etc.;
- patients who had severe visceral bleeding or intracranial haemorrhage before enrolment; any arterial or venous thrombosis within 6 months before screening;
- patients with severe cardiovascular diseases or arrhythmias that increase the risk of thrombus formation, coronary stent placement, angioplasty, and coronary artery bypass grafts within the prior 6 months;
- patients who had received platelet-producing drugs such as recombinant human interleukin 11(rhIL-11) within 1 week before the administration of the study drug;
- haemoglobin <50g/L after red blood cell transfusion or erythropoietin treatment or absolute neutrophil count <1.0×109/L after granulocyte colony-stimulating factor treatment;
- patients participating in clinical trials or who participated in an investigational drug trial within 4 weeks and received study treatment or investigational devices;
- and patients who were considered by the investigator to be inappropriate for inclusion for other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
To explore the early intervention timing of recombinant human thrombopoietin (rhTPO) for cancer treatment-induced thrombocytopenia (CTIT) in cervical squamous cell carcinoma (CSCC) patients during concurrent chemoradiotherapy.
- Conditions
- Cervical Squamous Cell Carcinoma
- Being tested
- rhTPO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhTPODrug
receiving rhTPO treatment when they occurred G1(100×109/L>PLT(Platelet)>75×109/L) CTIT at first presentation during CCRT
rhTPODrug
receiving rhTPO treatment when they occurred G1(75×109/L>PLT>50×109/L) CTIT at first presentation during CCRT
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1 | Experimental | receiving rhTPO treatment when they occurred G1(100×109/L>PLT(Platelet)>75×109/L) CTIT at first presentation during CCRT(Concurrent Chemoradiotherapy) Receives: Drug: rhTPO |
| Experimental group 2 | Experimental | receiving rhTPO treatment when they occurred G2(75×109/L>PLT(Platelet)>50×109/L) CTIT at first presentation during CCRT(Concurrent Chemoradiotherapy) Receives: Drug: rhTPO |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of severe CTIT (Cancer Treatment-Induced Thrombocytopenia , Grade 3 - Grade 5)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Feb 2021
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mei Feng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mei Feng, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649395
- Sponsor's protocol ID
- SCCHEC-02-2022-008
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Early Treatment of Recombinant Human Thrombopoietin for Chemoradiation Induced Thrombocytopenia in Cervical Squamous Cell Carcinoma Patient
- ClinicalTrials.gov ID
- NCT07649395
- Acronym / sponsor ID
- SCCHEC-02-2022-008
- Conditions
- Cervical Squamous Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Mei FengUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the early intervention timing of recombinant human thrombopoietin (rhTPO) for cancer treatment-induced thrombocytopenia (CTIT) in cervical squamous cell carcinoma (CSCC) patients during concurrent chemoradiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 | Experimental | Drug: rhTPOreceiving rhTPO treatment when they occurred G1(100×109/L>PLT(Platelet)>75×109/L) CTIT at first presentation during CCRT(Concurrent Chemoradiotherapy) |
| Experimental group 2 | Experimental | Drug: rhTPOreceiving rhTPO treatment when they occurred G2(75×109/L>PLT(Platelet)>50×109/L) CTIT at first presentation during CCRT(Concurrent Chemoradiotherapy) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- KPS(Karnofsky Performance Status) >60 points;
- histopathologically or cytologically confirmed stage I-IVa CSCC (FIGO 2018); 3.18-70 years; receiving radical CCRT;
- 4.receiving rhTPO treatment when they occurred G1 or G2 CTIT at first presentation during CCRT; 5.expected survival time ≥6 months
Key exclusion criteria (8 listed)
- patients with haematopoietic system diseases, including lymphoma, leukaemia, aplastic anaemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndromes;
- patients who had experienced non-CTIT within 6 months before screening, including but not limited to EDTA(Ethylenediaminetetraacetic acid)-dependent pseudothrombocytopenia, hypersplenism, infection, bleeding, etc.;
- patients who had severe visceral bleeding or intracranial haemorrhage before enrolment; any arterial or venous thrombosis within 6 months before screening;
- patients with severe cardiovascular diseases or arrhythmias that increase the risk of thrombus formation, coronary stent placement, angioplasty, and coronary artery bypass grafts within the prior 6 months;
- patients who had received platelet-producing drugs such as recombinant human interleukin 11(rhIL-11) within 1 week before the administration of the study drug;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhTPOreceiving rhTPO treatment when they occurred G1(100×109/L>PLT(Platelet)>75×109/L) CTIT at first presentation during CCRT | Drug | Experimental group 1 |
| rhTPOreceiving rhTPO treatment when they occurred G1(75×109/L>PLT>50×109/L) CTIT at first presentation during CCRT | Drug | Experimental group 2 |
Primary outcome
the incidence of severe CTIT (Cancer Treatment-Induced Thrombocytopenia , Grade 3 - Grade 5)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rhTPO in people with Cervical Squamous Cell Carcinoma, run by Mei Feng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of severe CTIT (Cancer Treatment-Induced Thrombocytopenia , Grade 3 - Grade 5) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.