Thymic CarcinomaPhase 2NCT06019468
Neoadjuvant Treatment For Locally Advanced Thymic Cancer
A Phase 2 study testing Envolizumab combined with radiotherapy in people with Thymic Carcinoma, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
The aims of this study are to verify the feasibility, effectiveness, and safety of the combination of enrolizumab and radiotherapy for neoadjuvant treatment for locally advanced thymic carcinoma, and to provide recommendations for the establishment of unified evaluation criteria for the neoadjuvant therapy of thymic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thymic Carcinoma
- What is being tested?
- Envolizumab combined with radiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2023to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Pathologically confirmed as thymic carcinoma;
- Clinical staging III-IVA (TNM staging system), non-myasthenia gravis (MG) patients, expected to undergo surgical resection;
- On the day when the subject signs the informed consent form, they are ≥ 18 years old and<75 years old, regardless of gender;
- The subjects are able to understand the informed consent form, voluntarily participate, and sign the informed consent form;
- Subjects who have not received any anti-thymic tumor treatment in the past, including but not limited to systemic chemotherapy, radiotherapy, or immunotherapy (only those who have received traditional Chinese medicine treatment for anti-tumor indications are allowed to be included, and a cleaning period of at least 2 weeks is required);
- At least 1 measurable lesion (according to the solid tumor efficacy evaluation standard RECIST V1.1);
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- Physical fitness score of 0 or 1 (ECOG scoring system of the Eastern Cancer Collaborative Group in the United States);
- Female subjects with fertility must have a negative serum pregnancy test within 7 days before the first administration;
- Female subjects with fertility or male subjects with partners with fertility agree to use efficient contraceptive measures (with an annual failure rate of less than 1%) from 7 days before the first administration until 24 weeks after the end of administration;
- The main organ functions within 7 days before the first administration meet the following standards:
- Bone marrow function: hemoglobin ≥ 10.0 g/dL (no blood transfusion received within 28 days before hemoglobin test), absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L (no platelet transfusion or IL-11 treatment received within 14 days prior to platelet count test);
- Coagulation function: INR and PT<1.5 × ULN, APTT ≤ 1.5 × ULN;
- Liver function: transaminases (ALT and AST) ≤ 2.5 × ULN; Total bilirubin ≤ 1.5 × ULN (total bilirubin ≤ 2.5 in subjects with Gilbert's syndrome or liver metastasis) × ULN);
- Renal function: serum creatinine clearance rate ≥ 60 mL/min (calculated according to Cockcroft Fault formula);
- Adequate lung function: According to the doctor's judgment, lung function can meet the requirements of thymectomy surgery.
Who cannot join
- Pathologically confirmed as a thymic neuroendocrine tumor;
- Subjects who have undergone major surgical treatment (such as abdominal or thoracic surgery; excluding diagnostic puncture or peripheral vascular pathway replacement surgery) or have not recovered from surgical treatment within 28 days before the administration of this trial;
- Within 14 days before the first administration of this study, systemic corticosteroids (≥ 10 mg/day prednisone, or equivalent amounts of other corticosteroids) or immunosuppressive therapy are required for 7 consecutive days; Excluding inhalation or local application of hormones, or receiving physiological replacement doses of hormone therapy due to adrenal insufficiency; Allow short-term (<7 days) use of corticosteroids for prevention (such as contrast agent allergies) or treatment of non-autoimmune diseases (such as delayed hypersensitivity reactions caused by exposure to allergens);
- Received live vaccines (including attenuated live vaccines) within 28 days prior to administration in this study;
- Previously or currently suffering from interstitial pneumonia/lung disease that requires systemic hormone therapy;
- Previously or currently suffering from autoimmune diseases, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener syndrome (granulomatosis of vasculitis, Graves disease, rheumatoid arthritis, pituitary inflammation, uveitis), autoimmune hepatitis, systemic sclerosis (scleroderma, etc.), Hashimoto's thyroiditis (exceptions see below), autoimmune vasculitis Autoimmune neuropathy (Guillain Barre syndrome), etc. The following cases are excluded: type I diabetes, hypothyroidism with stable hormone replacement therapy (including hypothyroidism caused by autoimmune thyroid disease), psoriasis or vitiligo without systemic treatment;
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- Other malignant tumors were combined within 5 years before the first administration, excluding cured skin squamous cell carcinoma, basal cell carcinoma, non-muscle invasive bladder cancer, localized low-risk prostate (defined as stage ≤ T2a, Gleason score ≤ 6, and PSA ≤ 10ng/mL at the time of diagnosis of prostate cancer (if measured, patients who have received radical treatment and have no PSA biochemical relapse can participate in this study), and in situ cervical/breast cancer;
- Have uncontrolled heart, kidney, gastrointestinal tract, infectious diseases and other complications;
- Previous history of allogeneic bone marrow or organ transplantation;;
- Previously treated with any antibody/drug (immune checkpoint) targeting T cell co-regulatory proteins, such as anti PD (L) 1, CTLA-4, 4-1BB, LAG 3, TIM 3, or anti CD127; Previously received anti-tumor vaccine treatment
- Previous history of allergic reactions to antibody-based drugs and intolerance (≥ Level 3 NCI-CTCAE V5.0); Any past history of rapid allergic reactions and uncontrollable asthma (i.e. uncontrollable asthma symptoms of 3 or more of the 3 or more characteristics of partially controlled asthma); Previous obvious allergies to drugs (such as severe allergic reactions, immune-mediated hepatotoxicity, immune-mediated thrombocytopenia or anemia);
- Pregnant and/or lactating women;
- Other situations that may affect the safety or compliance of drug treatment in this study, including but not limited to mental illness, uncontrolled large amounts of serous fluid accumulation, or subjects who require repeated drainage (recurrence within 2 weeks after intervention) with moderate to large amounts of serous fluid accumulation, cachexia, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality
Deping Zhao, zdp1992@163.com
About this study
Official title: Clinical Study of Envolizumab Combined With Radiotherapy for Neoadjuvant Treatment of Locally Advanced Thymic Cancer
The aims of this study are to verify the feasibility, effectiveness, and safety of the combination of enrolizumab and radiotherapy for neoadjuvant treatment for locally advanced thymic carcinoma, and to provide recommendations for the establishment of unified evaluation criteria for the neoadjuvant therapy of thymic cancer by evaluating the pathological remission status of thymic cancer specimens after neoadjuvant treatment.
Read the detailed description
For patients with locally advanced thymic carcinoma, it is often difficult to perform radical resection. Numerous studies have reported that neoadjuvant therapy can improve the surgical resection rate of thymic tumors by reducing the extent of tumor invasion and eliminating small metastatic lesions, thereby improving patient survival. However, the efficacy of neoadjuvant immunotherapy combined with chemotherapy is limited. This study intends to conduct a single-arm, phase II clinical trial of neoadjuvant immunotherapy combined with radiotherapy for locally advanced thymic carcinoma to verify the feasibility and safety of neoadjuvant immunotherapy combined with radiotherapy. Meanwhile, the investigators evaluate the pathological remission of postoperative specimens to provide recommendations for establishing pathological evaluation criteria for neoadjuvant therapy for thymic carcinoma.
- Conditions
- Thymic Carcinoma
- Being tested
- Envolizumab combined with radiotherapy
- Medical subject headings
- Thymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Envolizumab combined with radiotherapyOther
Also called KN035
Application of Envolizumab combined with radiotherapy for neoadjuvant treatment of locally advanced thymic cancer. Firstly, 20-40Gy radiation therapy was administered 10-20 times. Within one week after the start of radiation therapy, Envolizumab (300 mg, D1, Q3W, subcutaneous injection) was administered. Immunotherapy was maintained for 2-4 cycles, and surgery was performed after evaluation by the attending physician.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant immunotherapy combined with radiotherapy | Experimental | Treatment arms comprise 10-20 cycles of radiotherapy and 2-4 cycles of maintenance therapy with Envolizumab Receives: Other: Envolizumab combined with radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate（ORR）
ORR was defined as the best overall response (BoR), the proportion of participants in complete and partial response among the number of participants in each treatment group who received at least one medication.
Measured: 24 hour
Secondary outcomes (5)
Disease control rate（DCR）
DCR is defined as the proportion of imaging findings of CR, PR, and stable disease (SD) in all subjects evaluated according to RECIST V1.1 after completing neoadjuvant immunotherapy combined with radiotherapy
Measured: 24 hours
Radical resection rate（R0）
Pathological evaluation of the tumor margin, and based on whether the margin is gross or microscopic positive, it is divided into radical resection (R0), microscopic residual lesion (R1), or gross residual lesion (R2)
Measured: 24 hours
Pathological remission rate
Conduct pathological evaluation based on postoperative specimens to evaluate the percentage of surviving tumor cells, necrosis, and interstitial components in the original tumor bed area.
Measured: 7 days
disease-free survival（DFS）
The time interval between receiving surgical treatment and tumor recurrence or death due to tumor progression
Measured: 5 years
overall survival（OS）
The time interval between receiving surgical treatment and the patient's death due to any reason, and the patient is still alive during the final follow-up, with the survival time ending at the last follow-up.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start4 Nov 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thymic 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deping Zhao, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Deping Zhao, MD,PhD, Principal investigator, Shanghai Pulmonary Hospital, School of Medicine, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019468
- Sponsor's protocol ID
- STAR005
- Status last verified
- May 2026
- First submitted
- 25 Aug 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Envolizumab Combined With Radiotherapy for Neoadjuvant Treatment of Locally Advanced Thymic Cancer
- ClinicalTrials.gov ID
- NCT06019468
- Acronym / sponsor ID
- STAR005
- Conditions
- Thymic Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 4 Nov 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 31 Aug 2023 (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.
The aims of this study are to verify the feasibility, effectiveness, and safety of the combination of enrolizumab and radiotherapy for neoadjuvant treatment for locally advanced thymic carcinoma, and to provide recommendations for the establishment of unified evaluation criteria for the neoadjuvant therapy of thymic cancer by evaluating the pathological remission status of thymic cancer specimens after neoadjuvant treatment.
Detailed description
For patients with locally advanced thymic carcinoma, it is often difficult to perform radical resection. Numerous studies have reported that neoadjuvant therapy can improve the surgical resection rate of thymic tumors by reducing the extent of tumor invasion and eliminating small metastatic lesions, thereby improving patient survival. However, the efficacy of neoadjuvant immunotherapy combined with chemotherapy is limited. This study intends to conduct a single-arm, phase II clinical trial of neoadjuvant immunotherapy combined with radiotherapy for locally advanced thymic carcinoma to verify the feasibility and safety of neoadjuvant immunotherapy combined with radiotherapy. Meanwhile, the investigators evaluate the pathological remission of postoperative specimens to provide recommendations for establishing pathological evaluation criteria for neoadjuvant therapy for thymic carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant immunotherapy combined with radiotherapy | Experimental | Other: Envolizumab combined with radiotherapyTreatment arms comprise 10-20 cycles of radiotherapy and 2-4 cycles of maintenance therapy with Envolizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Pathologically confirmed as thymic carcinoma;
- Clinical staging III-IVA (TNM staging system), non-myasthenia gravis (MG) patients, expected to undergo surgical resection;
- On the day when the subject signs the informed consent form, they are ≥ 18 years old and<75 years old, regardless of gender;
- The subjects are able to understand the informed consent form, voluntarily participate, and sign the informed consent form;
- Subjects who have not received any anti-thymic tumor treatment in the past, including but not limited to systemic chemotherapy, radiotherapy, or immunotherapy (only those who have received traditional Chinese medicine treatment for anti-tumor indications are allowed to be included, and a cleaning period of at least 2 weeks is required);
Key exclusion criteria (13 listed)
- Pathologically confirmed as a thymic neuroendocrine tumor;
- Subjects who have undergone major surgical treatment (such as abdominal or thoracic surgery; excluding diagnostic puncture or peripheral vascular pathway replacement surgery) or have not recovered from surgical treatment within 28 days before the administration of this trial;
- Within 14 days before the first administration of this study, systemic corticosteroids (≥ 10 mg/day prednisone, or equivalent amounts of other corticosteroids) or immunosuppressive therapy are required for 7 consecutive days; Excluding inhalation or local application of hormones, or receiving physiological replacement doses of hormone therapy due to adrenal insufficiency; Allow short-term (<7 days) use of corticosteroids for prevention (such as contrast agent allergies) or treatment of non-autoimmune diseases (such as delayed hypersensitivity reactions caused by exposure to allergens);
- Received live vaccines (including attenuated live vaccines) within 28 days prior to administration in this study;
- Previously or currently suffering from interstitial pneumonia/lung disease that requires systemic hormone therapy;
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 |
|---|---|---|
| Envolizumab combined with radiotherapyAlso: KN035Application of Envolizumab combined with radiotherapy for neoadjuvant treatment of locally advanced thymic cancer. Firstly, 20-40Gy radiation therapy was administered 10-20 times. Within one week after the start of radiation therapy, Envolizumab (300 mg, D1, Q3W, subcutaneous injection) was administered. Immunotherapy was maintained for 2-4 cycles, and surgery was performed after evaluation by the attending physician. | Other | Neoadjuvant immunotherapy combined with radiotherapy |
Primary outcome
objective response rate（ORR）
Time frame: 24 hour
ORR was defined as the best overall response (BoR), the proportion of participants in complete and partial response among the number of participants in each treatment group who received at least one medication.
5 secondary outcomes
Disease control rate（DCR）
Time frame: 24 hours
Radical resection rate（R0）
Time frame: 24 hours
Pathological remission rate
Time frame: 7 days
disease-free survival（DFS）
Time frame: 5 years
overall survival（OS）
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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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.
Deping Zhao, MD,PhD principal investigator
Shanghai Pulmonary Hospital, School of Medicine, Tongji University
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 Envolizumab combined with radiotherapy in people with Thymic Carcinoma, 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 13 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: looking for participants now, as of the sponsor's last update on 8 May 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juemin Yu (+8615927548511, yujm96@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate（ORR） (time frame: 24 hour). 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 8 May 2026.