Poorly Differentiated Thyroid CarcinomaPhase 2NCT03387943
PLD Combined With Cisplatin in the Treatment of Advanced Poorly Differentiated Thyroid Carcinoma
A Phase 2 study testing PLD and Cisplatin in people with Poorly Differentiated Thyroid Carcinoma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This is a prospective, multicenter, open label Phase II Clinical Trial. 30 advanced poorly differentiated thyroid carcinoma patients who were histopathologically confirmed inoperable were enrolled in this study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Poorly Differentiated Thyroid Carcinoma
- What is being tested?
- PLD and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2017to 31 Dec 2019
- Phase
- Phase 2
- 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
- Volunteer to participate and sign the informed consent form;
- Age :18-70 years old;
- Histopathologically confirmed inoperable advanced poorly differentiated thyroid carcinoma;
- Previously received surgery, I131 treatment, radiotherapy, chemotherapy patients can be enrolled；
- At least one measurable lesion according to the solid tumor efficacy evaluation criteria (RECIST 1.1);
- Expected survival time ≥ 3 months;
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- Karnofsky score ≥70;
- Blood test：ANC ≥1.5×109/L； PLT ≥75×109/L；Hb ≥90g/L;
- Liver function:Serum bilirubin (SB) level:≤ normal upper limit（ULN）2 times; aspartate aminotransferase(AST) and alanine aminotransferase(ALT) ≤ ULN 2.5times; or ≤ ULN 5times if Liver metastases are present;
- Renal function: Serum creatinine ≤ ULN 1.5times;
- LVEF ≥ 50%;
- No serious complications such as active digestive tract hemorrhage, perforation, jaundice, gastrointestinal obstruction, noncancerous fever > 38℃;
- Subjects are well-behaved, able to undergo the follow-up efficacy and adverse reactions according to the program requirements.
Who cannot join
- Active or uncontrolled severe infection (≥CTCAE grade 2 infection)；
- Previously received anthracycline-based regimen: the cumulative dose of doxorubicin at or above 500 mg / m2 or the cumulative dose of epirubicin reached or exceeded 800 mg / m2;
- The New York Heart Association (NYHA) graded class II or above heart disease patients previously or at present;
- Patients with CNS disorders or CNS metastases;
- Allergic to chemotherapeutic drugs or their excipients or intolerant patients;
- Received any other test drug treatment within 30 days of the first chemotherapy administration;
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- Pregnant or lactating women;
- Arterial/venous thrombosis occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis, and pulmonary embolism;
- History of aneurysm;
- Neurological disorders with a history of epilepsy or ataxia require treatment;
- A history of drug abuse and incapable of abstinence or mental disorder;
- A history of peripheral neuropathy and the muscle strength is below level 3;
- Suffering from other diseases and complications of hand-foot syndrome;
- Researchers think it is not suitable for enrolling.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Zhejiang
haiyan yang, doctor
About this study
Official title: A Prospective, Multicenter, Open Label Phase Ⅱ Clinical Trial of Doxorubicin Hydrochloride Liposome Injection Combined With Cisplatin in the Treatment of Advanced Poorly Differentiated Thyroid Carcinoma
This is a prospective, multicenter, open label Phase II Clinical Trial. 30 advanced poorly differentiated thyroid carcinoma patients who were histopathologically confirmed inoperable were enrolled in this study.
Read the detailed description
Subjects will receive the treatment regimen as follow:
intravenous infusion of liposomal doxorubicin 35 mg/m2, d1; cisplatin 75 mg/m2, drip, total dose should be carried out on d1-3; once every 21days, for 6 cycles. Stop the treatment if the patients have progressed or intolerated to the toxicity. The primary endpoint is disease control rate(DCR), the secondary endpoint is overall survival (OS), progression-free survival (PFS), safety and quality of life assessment(QoL).
- Conditions
- Poorly Differentiated Thyroid Carcinoma
- Being tested
- PLD, Cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLDDrug
Also called duomeisu
intravenous infusion of liposomal doxorubicin 35 mg/m2, d1,once every 21days, for 6 cycles.
CisplatinDrug
Also called shunbo
cisplatin 75 mg/m2, drip, total dose should be carried out on d1-3; once every 21days, for 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| PLD plus Cisplatin | Experimental | liposomal doxorubicin(PLD) 35 mg/m2,iv,d1, plus cisplatin 75 mg/m2,drip,d1-3, once every 21days, for 6 cycles, to progression or intolerance. Receives: Drug: PLD; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease control rate(DCR)
the rate of CR,PR and SD
Measured: disease control rate will be evaluated every 2 cycles (each cycle is 21 days) from date of administration of drugs until the date of first documented progression，up to 18 months.
Secondary outcomes (4)
OS
overall survival
Measured: From date of randomization until the date of death from any cause,assessed up to 18 months.
PFS
progression-free survival
Measured: From date of randomization until the date of first documented disease progression or date of death from any case,whichever came first,assessed up to 18 months.
Incidence of adverse events assessed by number and severity of adverse event in the treatment.
Evaluate the adverse reaction rate of drugs assessed by number and severity of adverse events in the treatment of advanced thyroid poorly differentiated carcinoma.
Measured: A summary of adverse events of each cycle,from date of administration of drugs until 30 days after the last chemotherapy or progression,whichever came first,assessed up to 18 months.
quality of life assessment
Evaluate the QoL according to Functional Assessment of Cancer Therapy.
Measured: It will be assessed before the administration of drugs at each first day of the chemotherapy cycle,up to 6 cycles,each cycle is 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start6 Mar 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poorly Differentiated Thyroid CarcinomaStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- minghua ge, doctor, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387943
- Sponsor's protocol ID
- CSPC-DMS-CG-01
- Status last verified
- Feb 2017
- First submitted
- 11 Dec 2017
- Last updated
- 3 Jan 2018
- 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 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Open Label Phase Ⅱ Clinical Trial of Doxorubicin Hydrochloride Liposome Injection Combined With Cisplatin in the Treatment of Advanced Poorly Differentiated Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT03387943
- Acronym / sponsor ID
- CSPC-DMS-CG-01
- Conditions
- Poorly Differentiated Thyroid Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 2 Jan 2018 (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.
This is a prospective, multicenter, open label Phase II Clinical Trial. 30 advanced poorly differentiated thyroid carcinoma patients who were histopathologically confirmed inoperable were enrolled in this study.
Detailed description
Subjects will receive the treatment regimen as follow:
intravenous infusion of liposomal doxorubicin 35 mg/m2, d1; cisplatin 75 mg/m2, drip, total dose should be carried out on d1-3; once every 21days, for 6 cycles. Stop the treatment if the patients have progressed or intolerated to the toxicity. The primary endpoint is disease control rate(DCR), the secondary endpoint is overall survival (OS), progression-free survival (PFS), safety and quality of life assessment(QoL).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PLD plus Cisplatin | Experimental | Drug: PLD, Drug: Cisplatinliposomal doxorubicin(PLD) 35 mg/m2,iv,d1, plus cisplatin 75 mg/m2,drip,d1-3, once every 21days, for 6 cycles, to progression or intolerance. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Volunteer to participate and sign the informed consent form;
- Age :18-70 years old;
- Histopathologically confirmed inoperable advanced poorly differentiated thyroid carcinoma;
- Previously received surgery, I131 treatment, radiotherapy, chemotherapy patients can be enrolled；
- At least one measurable lesion according to the solid tumor efficacy evaluation criteria (RECIST 1.1);
Key exclusion criteria (14 listed)
- Active or uncontrolled severe infection (≥CTCAE grade 2 infection)；
- Previously received anthracycline-based regimen: the cumulative dose of doxorubicin at or above 500 mg / m2 or the cumulative dose of epirubicin reached or exceeded 800 mg / m2;
- The New York Heart Association (NYHA) graded class II or above heart disease patients previously or at present;
- Patients with CNS disorders or CNS metastases;
- Allergic to chemotherapeutic drugs or their excipients or intolerant patients;
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 |
|---|---|---|
| PLDAlso: duomeisuintravenous infusion of liposomal doxorubicin 35 mg/m2, d1,once every 21days, for 6 cycles. | Drug | PLD plus Cisplatin |
| CisplatinAlso: shunbocisplatin 75 mg/m2, drip, total dose should be carried out on d1-3; once every 21days, for 6 cycles. | Drug | PLD plus Cisplatin |
Primary outcome
disease control rate(DCR)
Time frame: disease control rate will be evaluated every 2 cycles (each cycle is 21 days) from date of administration of drugs until the date of first documented progression，up to 18 months.
the rate of CR,PR and SD
4 secondary outcomes
OS
Time frame: From date of randomization until the date of death from any cause,assessed up to 18 months.
PFS
Time frame: From date of randomization until the date of first documented disease progression or date of death from any case,whichever came first,assessed up to 18 months.
Incidence of adverse events assessed by number and severity of adverse event in the treatment.
Time frame: A summary of adverse events of each cycle,from date of administration of drugs until 30 days after the last chemotherapy or progression,whichever came first,assessed up to 18 months.
quality of life assessment
Time frame: It will be assessed before the administration of drugs at each first day of the chemotherapy cycle,up to 6 cycles,each cycle is 21 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
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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.
minghua ge, doctor principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PLD and Cisplatin in people with Poorly Differentiated Thyroid Carcinoma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. 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 13 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 3 Jan 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jiandong nie, doctor (0311-66575708, niejd@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease control rate(DCR) (time frame: disease control rate will be evaluated every 2 cycles (each cycle is 21 days) from date of administration of drugs until the date of first documented progression，up to 18 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 3 Jan 2018.