Thymic Epithelial TumorPhase 2NCT04667793
Clinical Study of Neoadjuvant PD-1 Antibody (Toripalimab) Plus Chemotherapy for Locally Advanced Thymic Epithelial Tumor
A Phase 2 study testing Toripalimab + Chemotherapy in people with Thymic Epithelial Tumor, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
This is a phase II, single-arm, open-label study to evaluate the efficacy and safety of neoadjuvant Toripalimab + chemotherapy followed by radical surgery as first-line treatment in patients with locally advanced thymic epithelial tumor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thymic Epithelial Tumor
- What is being tested?
- Toripalimab + Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2021to 30 Apr 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Thymic epithelial tumor confirmed by needle biopsy;
- No systemic metastasis confirmed by PET-CT;
- Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
- At stage III-IVA (masaoka-koga) as identified by chest CT or MRI;
- With the feasibility or anticipated feasibility after neoadjuvant therapy to receive radical surgery;
- Aged 18-75 years;
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- At least 1 measurable lesion according to RECIST 1.1;
- Patients with good function of other main organs (liver, kidney, blood system, etc.):
- ANC count ≥1.5×10^9/L, platelet count ≥100×10^9/L，hemoglobin ≥90 g/L;
- the international standard ratio of prothrombin time (INR) and prothrombin time (PT) < 1.5 times of upper limit of normal (ULN);
- partial thromboplastin time (APTT) ≤1.5×ULN;
- total bilirubin ≤1.5×ULN;
- alanine aminotransferase (ALT) aspartate aminotransferase (AST) ≤2.5×ULN, or ALT and AST ≤5×ULN in the patients with liver metastatic tumor.
- The child-bearing female must undergo pregnancy test within 7 days before starting the treatment and the result shall be negative. Reliable contraceptive measures, such as intrauterine device, contraceptive pill and condom, shall be adopted during the trial and within 30 days after completion of the trial. The child-bearing male shall use condom for contraception during the trial and within 30 days after completion of the trial;
- The patient shall sign the Informed Consent Form.
Who cannot join
- Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;
- Administration of any Chinese medicine against cancer before administration of the drug;
- Participants with other cancer (excluding cervical carcinoma in situ, cured basal cell carcinoma, bladder epithelial tumor [including TA and tis]) within five years before the start of this study;
- Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;
- With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
- Antibiotics were used to treat the infection for 4 weeks prior to the start of the trial;
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- Participants who were systemically treated with corticosteroids (prednisone or other corticosteroids >10 mg/ day) or other immunosuppressive agents within 2 weeks prior to first administration. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy with a dose of less than 10 mg/ day of prednisone are permitted;
- Participants who are allergic to the test drug or any auxiliary materials;
- Participants with active hepatitis B, hepatitis C or HIV;
- The vaccine was administered within 4 weeks of the start of the trial;
- Participants who have undergone major surgery or severe trauma in other systems within 2 months before the start of this trial;
- Pleural effusion, pericardial effusion or ascites that are not clinically controlled and require pleural puncture or abdominal puncture drainage within 2 weeks before inclusion;
- The patients have active pia meningioma, uncontrolled or untreated brain metastases;
- Pregnant or lactating women;
- Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
- Participated in another therapeutic clinical study;
- Other factors that researchers think it is not suitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, 200433
Peng Zhang, PhD, 021-55672180, zhangpeng1121@tongji.edu.cn
About this study
This is a phase II, single-arm, open-label study to evaluate the efficacy and safety of neoadjuvant Toripalimab + chemotherapy followed by radical surgery as first-line treatment in patients with locally advanced thymic epithelial tumor.
- Conditions
- Thymic Epithelial Tumor
- Being tested
- Toripalimab + Chemotherapy
- Medical subject headings
- Thymic epithelial tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toripalimab + ChemotherapyDrug
Toripalimab: 200mg, q3w, i.v., 2-4 cycles
Chemotherapy:
Thymoma: Cisplatin+Amycin+Cyclophosphamide Thymic carcinoma: Carboplatin+Paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| Thymic Epithelial Tumor | Experimental | For thymoma:
Neoadjuvant treatment stage: Toripalimab 240mg, q3w, i.v., 2-4 cycles; platinum-based chemotherapy (Carboplatin AUC 5, Amycin 50mg/m2, Cyclophosphamide 500mg/m2) q3w, i.v., 2-4 cycles, then receive chest CT evaluation.
Surgery stage: the patients will receive radical surgery after the neoadjuvant treatment.
Adjuvant treatment stage: the patients who did not receive 4 cycle therapy will receive 1-2 cycles therapy up to 4 cycles in total, the following therapy is according to the NCCN guidelines.
For thymic carcinoma:
Neoadjuvant treatment stage: Toripalimab 240mg, q3w, i.v., 2-4 cycles; platinum-based chemotherapy (Cisplatin 50mg/m2, Paclitaxel 200mg/m2) q3w, i.v., 2-4 cycles, then receive chest CT evaluation. Receives: Drug: Toripalimab + Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: frequency of severe adverse events
The frequency of severe adverse events from the participants enrolling to 30 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.
Measured: up to 5 months
Major pathologic response (MPR)
MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery.
Measured: up to 4 months
Secondary outcomes (4)
Objective response rate (ORR)
It refers to the proportion of patients who have had a complete response or partial response (according to RECIST1.1) as confirmed by CT evaluation after 3 weeks in all patients who have completed the neoadjuvant therapy. Only patients with measurable lesions at baseline will be analyzed.
Measured: up to 4 months
Disease-free survival (DFS)
It refers to the time from radical surgery to relapse or death of a participant due to disease progression. In the case of a patient who still survives at the time of analysis, the latest evaluation date will be used for interpolation (censoring).
Measured: up to 60 months
Overall survival (OS)
It is defined as the time from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date. In the event of a patient with the survival status unknown, the date when the patient is last known to be alive will be used for interpolation (censoring).
Measured: up to 60 months
Health related quality of life (HRQol)
The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (EORTC-QLQ-C30 \& LC13, Version 3). EORTC's QLQ-C30 \& LC13 (V3.0) is a core scale for lung cancer patients, with a total of 43 items. Among them, Item 29 and 30 are divided into seven grades, which are assigned with 1 to 7 scores according to the answer options. The other items are divided into 4 grades: Not at All, A Little, Quite a Bit, and Very Much, assigned with 1 to 4 scores respectively. The higher score, the worse quality.
Measured: up to 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 Dec 2020
- Study start31 Jan 2021
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thymic Epithelial TumorStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Zhang, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667793
- Sponsor's protocol ID
- ChestMate-001(FK-NEO-TET-001)
- Status last verified
- Apr 2023
- First submitted
- 5 Dec 2020
- Last updated
- 4 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Neoadjuvant PD-1 Antibody (Toripalimab) Plus Chemotherapy for Locally Advanced Thymic Epithelial Tumor
- ClinicalTrials.gov ID
- NCT04667793
- Acronym / sponsor ID
- ChestMate-001(FK-NEO-TET-001)
- Conditions
- Thymic Epithelial Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 31 Jan 2021 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 16 Dec 2020 (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 phase II, single-arm, open-label study to evaluate the efficacy and safety of neoadjuvant Toripalimab + chemotherapy followed by radical surgery as first-line treatment in patients with locally advanced thymic epithelial tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thymic Epithelial Tumor | Experimental | Drug: Toripalimab + ChemotherapyFor thymoma: Neoadjuvant treatment stage: Toripalimab 240mg, q3w, i.v., 2-4 cycles; platinum-based chemotherapy (Carboplatin AUC 5, Amycin 50mg/m2, Cyclophosphamide 500mg/m2) q3w, i.v., 2-4 cycles, then receive chest CT evaluation. Surgery stage: the patients will receive radical surgery after the neoadjuvant treatment. Adjuvant treatment stage: the patients who did not receive 4 cycle therapy will receive 1-2 cycles therapy up to 4 cycles in total, the following therapy is according to the NCCN guidelines. For thymic carcinoma: Neoadjuvant treatment stage: Toripalimab 240mg, q3w, i.v., 2-4 cycles; platinum-based chemotherapy (Cisplatin 50mg/m2, Paclitaxel 200mg/m2) q3w, i.v., 2-4 cycles, then receive chest CT evaluation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Thymic epithelial tumor confirmed by needle biopsy;
- No systemic metastasis confirmed by PET-CT;
- Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
- At stage III-IVA (masaoka-koga) as identified by chest CT or MRI;
- With the feasibility or anticipated feasibility after neoadjuvant therapy to receive radical surgery;
Key exclusion criteria (17 listed)
- Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;
- Administration of any Chinese medicine against cancer before administration of the drug;
- Participants with other cancer (excluding cervical carcinoma in situ, cured basal cell carcinoma, bladder epithelial tumor [including TA and tis]) within five years before the start of this study;
- Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;
- With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
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 |
|---|---|---|
| Toripalimab + ChemotherapyToripalimab: 200mg, q3w, i.v., 2-4 cycles Chemotherapy: Thymoma: Cisplatin+Amycin+Cyclophosphamide Thymic carcinoma: Carboplatin+Paclitaxel | Drug | Thymic Epithelial Tumor |
Primary outcome
Safety: frequency of severe adverse events
Time frame: up to 5 months
The frequency of severe adverse events from the participants enrolling to 30 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.
Major pathologic response (MPR)
Time frame: up to 4 months
MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery.
4 secondary outcomes
Objective response rate (ORR)
Time frame: up to 4 months
Disease-free survival (DFS)
Time frame: up to 60 months
Overall survival (OS)
Time frame: up to 60 months
Health related quality of life (HRQol)
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Toripalimab + Chemotherapy in people with Thymic Epithelial Tumor, run by Shanghai Pulmonary Hospital, Shanghai, China 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 15 inclusion and 17 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 4 Apr 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: frequency of severe adverse events (time frame: up to 5 months). The study lists 2 primary outcomes in all. 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 4 Apr 2023.