Recurrent / Metastatic Nasopharyngeal CancerPhase 1/2NCT05198531
To Evaluate the Safety and Efficacy of TQB2858 Injection to the Subjects With Recurrent/Metastatic Nasopharyngeal Cancer
A Phase 1/2 study testing TQB2858 Injection, Anlotinib Hydrochloride Capsule and Gemcitabine hydrochloride injection in people with Recurrent / Metastatic Nasopharyngeal Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 7 sites in China.
Trial summary
This study is a single-arm, randomized, open-label, multi-cohort Phase Ib clinical trial. The experimental drug is TQB2858 Injection. The trial was divided into 3 cohorts. Cohort 1 included patients with advanced nasopharyngeal carcinoma who had previously failed platinum-based chemotherapy and immune checkpoint… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent / Metastatic Nasopharyngeal Cancer
- What is being tested?
- TQB2858 Injection, Anlotinib Hydrochloride Capsule and Gemcitabine hydrochloride injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 7 sitesChina
- Study dates
- Jan 2022to Aug 2023
- Phase
- Phase 1/2
- 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
- 1 Voluntarily joined the study and provide written informed consent and authorization permitting release of Protected Health Information.
- 2 Male or female patient ≥18 and ≤75 years of age, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy ≥12 weeks.
- 3 Histologically or cytologically proven diagnosis of nasopharyngeal cancer (NPC), Stage IVb or not amenable for or local treatment (based on 2017, the 8th edition of the American Joint Committee on Cancer (AJCC) staging system of tumor-node-metastasis (TNM) of nasopharyngeal cancer).
- 4 Subject meets one of the following criteria:
- Arm 1: Progression (Tumor-imaging proven) after platinum-based chemotherapy and Tumor Immunotherapy (PD-1/PD-L1 Checkpoint Inhibitors, etc.).
- Attention: Progression during therapy or after therapy within 6 months, neoadjuvant/ adjuvant therapy, radical chemoradiotherapy are considered as the first-line treatment.
Show all 16Show fewer
- Arm 2 and 3: Not received systemic anti-tumor therapy for recurrent / metastatic nasopharyngeal cancer.
- Attention: Progression after therapy more than 6 months, neoadjuvant/ adjuvant therapy, radical chemoradiotherapy are not considered as the first-line treatment.
- 5 Have at least 1 measurable disease defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
- 6 Have adequate baseline function and performance status：
- a) Standard hematology test (no blood or product transfusions for a period of at least 7 days prior to enrollment).
- Hemoglobin (HGB) >90 g/L; ii. Neutrophil count (NEUT) ≥1.5 × 109/L; iii. Platelets (PLT) ≥75 × 109/L;
- b) Serum chemistry i. Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 upper limit of normal (ULN) or ≤ 5 x ULN for subjects with hepatic metastatic tumor; ii. Bilirubin ≤ 1.5 x ULN or ≤ 3.0 x ULN for subjects with Gilbert Syndrome; iii. Creatinine ≤ 1.5 x ULN or Creatinine Clearance ≥ 60 mL/min;
- c) Blood Coagulation Test i. Activated Partial Thromboplastin Time (APTT), International Normalized Ratio (INR) and Prothrombin Time (PT) ≤ 1.5 (No anticoagulant therapy);
- d) left ventricular ejection fraction (LVEF) ≥ 50%;
- 7 Women of child-bearing potential must agree to use contraceptive method(s) throughout the study and for at least 180 days after the last dose of assigned treatment. Serum pregnancy test negative within 7 days before enrollment and must be non-lactating.
Who cannot join
- 1 Complicated disease and history:
- Has developed other malignant tumors within 3 years or is currently suffering from;
- With factors affecting take medicine orally (such as unable to swallow drugs or bowel obstruction, etc.)
- Unmitigated toxic reactions above Common Terminology Criteria for Adverse Events (CTCAE) grade 1 due to any prior treatment, excluding hair loss and peripheral sensory nerve disorders related to platinum-based chemotherapy;
- Received major surgical treatment, significant traumatic injury or long-term unhealed wounds or fractures (excluding needle biopsy for diagnosis, endoscope, etc.) within 28 days prior to the commencement of study treatment;
- With arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage), deep venous thrombosis and pulmonary embolism;
Show all 39Show fewer
- With active pulmonary tuberculosis, idiopathic pulmonary fibrosis, organized pneumonia, drug-induced pneumonia, radiation pneumonia requiring treatment or active pneumonia with clinical symptoms;
- History of psychotropic substance abuse and inability to quit or with mental disorders;
- Received allogeneic bone marrow transplantation or solid organ transplantation;
- Subjects with any severe and/or uncontrolled disease:
- i. Uncontrolled hypertension (defined as systolic BP >150 mm Hg or diastolic BP > 100 mm Hg pressure)
- ii. Grade 2 or greater cardiac ischemia, myocardial infarction or cardiac arrhythmia (including QTc ≥ 480 ms) ;and New York Heart Association (NYHA) Grade II or greater congestive heart failure;
- iii. Active or uncontrolled infections;
- iv. Decompensated liver cirrhosis and active hepatitis (Hepatitis B reference: HBsAg positive, and HBV DNA> 2500 copy/mL or > 500 IU/mL; Hepatitis C reference: HCV antibody positive, and HCV RNA > ULN);
- v. Renal failure requiring hemodialysis or peritoneal dialysis；
- vi. Known history of immunodeficiency infection;
- vii. Urinalysis：urine protein ≥ ++，and confirmed 24-hour urinary protein > 1.0g;
- 2 Tumor-related symptoms and treatment:
- History of surgery, chemotherapy, radiation or other anti-tumor therapy within 4 weeks prior to enrollment (calculated from the date of the last dose);
- History of Chinese patent drugs with anti-tumor indications approved by National Medical Products Administration (NMPA) (including compound cantharide capsule, Kangai injection, Kanglaite capsule/injection, Aidi injection, Brucea oil injection/capsule, Xiaoaoping tablet/injection, Huabenin capsule, etc.) within 2 weeks before enrollment;
- History of Tumor Immunotherapy of TGF-β inhibition;
- Previously received bevacizumab, arotinib, apatinib, renvatinib or other anti-vascular targeted drug therapy;
- History of secondary radiotherapy;
- Imaging (CT or MRI) evidence of tumor invading the significant blood vessels or likely to invade and cause fatal massive bleeding during study, accessed by investigators;
- With uncontrolled pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
- Known uncontrolled or symptomatic active central nervous system (CNS) metastasis (characterized by clinical symptoms, brain edema, spinal cord compression, cancerous meningitis, leptomeningeal disease and /or progressive growth); (exclude those, with the history of CNS metastasis or spinal cord compression, clinical symptoms stabilized less than 4 weeks after discontinuation of dehydrants and steroids);
- 2 Research Treatment Related:
- History of live attenuated vaccine vaccination within 28 days prior to enrollment or planing of live attenuated vaccine vaccination during the study period;
- Definite bleeding tendency or bleeding symptoms with significant clinical significance within 28 days prior enrollment, including gastrointestinal bleeding, nasal bleeding (excluding epistaxis and retractive runny nose), and with hemorrhagic diseases or coagulation disorders;
- History of hemoptysis or hemoptysis within 28 days prior enrollment (defined as coughing or coughing out ≥ 1 teaspoon of blood or small blood clots or only coughing up blood without sputum) , blood in sputum are not excluded;
- Severe allergy history of antibody drugs or others;
- History of active autoimmune disease requiring systemic treatment within 2 years prior to enrollment (e.g. palliative drugs, corticosteroids, or immunosuppressants) .
- i. Including autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism or multiple sclerosis;
- ii. Exclude Skin diseases without systemic treatment, such as vitiligo, psoriasis and hair loss；
- iii. Including asthma requiring medical intervention with bronchodilators;
- iv.Alternative therapy (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered as systemic therapy;
- Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy. (dose of >10mg/ day prednisone or other equivalent efficacy hormone), and continued to use within 2 weeks prior to enrollment;
- 4 History of participating in other anti-tumor clinical trials in the previous 4 weeks;
- 5 Other damage to the safety of patients or other situations affecting patients to complete the study, assessed by investigators.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410006
Yaqian Han, Master, 18673176667, hanyaqian@hnca.org.cn
- Recruiting
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Weidong Li, Master, 13725334110, lwdlyn_hky@126.com
- Recruiting
Sun-Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Li Zhang, Master, 13902282893, zhangli6@mail.sysu.edu.cn
- Recruiting
Hainan General Hospital
Haikou, Hainan, 570100
Junmin Chen, Bachelor, 18889808030, 18889808030@139.com
- Recruiting
Guangxi Tumor Hospital
Nanning, Guangxi, 530021
Song Qu, Doctor, 13607887386, daisyqs2002@163.com
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518000
Shubin Wang, Doctor, 13823394076, wangshubin2013@163.com
- Recruiting
The Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai, Guangdong, 519000
Si Yang Wang, Bachelor, 13570608929, 13570608929@163.com
About this study
Official title: Phase Ib Clinical Study to Evaluate the Safety and Efficacy of TQB2858 Injection to the Subjects With Recurrent/Metastatic Nasopharyngeal Cancer
This study is a single-arm, randomized, open-label, multi-cohort Phase Ib clinical trial. The experimental drug is TQB2858 Injection. The trial was divided into 3 cohorts. Cohort 1 included patients with advanced nasopharyngeal carcinoma who had previously failed platinum-based chemotherapy and immune checkpoint inhibitors (programmed cell death protein 1 (PD-1)/ Programmed death-ligand 1 (PD-L1), etc.). Cohorts 2 and 3 were randomized into patients with advanced, untreated nasopharyngeal carcinoma who had not received prior systemic therapy. A total of 60-90 subjects are required.
- Being tested
- TQB2858 Injection, Anlotinib Hydrochloride Capsule, Gemcitabine hydrochloride injection, Cisplatin Injection
- Medical subject headings
- Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2858 InjectionDrug
TQB2858 Injection, a bifunctional fusion protein against Programmed death ligand 1 (PD-LI) and transforming growth factor-β (TGF-β). TQB2858 Injection blocks the PD-1/PD-L1 pathway and neutralizes TGF-β in the tumor microenvironment.
Anlotinib Hydrochloride CapsuleDrug
Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.
Gemcitabine hydrochloride injectionDrug
Gemcitabine hydrochloride, cell cycle-specific antimetabolites, mainly acting on tumor cells in the DNA synthesis phase (S phase cell). Under certain conditions, it can prevent the progression from G1 phase to S phase.
Cisplatin InjectionDrug
After cisplatin enters cells, it reacts with DNA to form cross-links between two points or two strands in DNA, thereby inhibiting DNA replication and transcription, resulting in DNA breaks and miscoding.
| Study group | Role | What they receive |
|---|---|---|
| TQB2858 Injection combining with other drugs | Experimental | Combination 1 is TQB2858 Injection and Anlotinib Hydrochloride Capsules. Combination 2 is TQB2858 Injection, Gemcitabine Hydrochloride Injection and Cisplatin Injection for 4-6 cycles of induction chemotherapy, then using TQB2858 Injection and Anlotinib Hydrochloride Capsules for maintenance treatment.
Combination 3 is TQB2858 Injection, Gemcitabine Hydrochloride Injection, Cisplatin Injection and Anlotinib Hydrochloride Capsules for 4-6 cycles of induction chemotherapy, then using TQB2858 Injection and Anlotinib Hydrochloride Capsules for maintenance treatment. Receives: Drug: TQB2858 Injection; Drug: Anlotinib Hydrochloride Capsule; Drug: Gemcitabine hydrochloride injection; Drug: Cisplatin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Measured: Baseline up to PD/die, about 20 months
Secondary outcomes (5)
Objective Response Rate(ORR)
The percentage of participants with a best overall response defined as complete response (CR) or partial response (PR).
Measured: Baseline to CR/PR, about 16 months
Progression-free survival (PFS)
The time from enrollment to the date of the first documentation of objective progression of disease or death due to any cause, whichever occurs first.
Measured: Baseline to PD/die, about 20 months
Disease Control rate (DCR)
Calculated as the percentage of participants with best overall response of CR, PR, stable disease (SD) and Non-CR/Non-progressive disease (PD).
Measured: Baseline to CR/PR/SD, about 16 months
Duration of Overall Response (DOR)
The time from the date of participants with a first overall response defined as complete response (CR) or partial response (PR) to the date of the first documentation of objective progression of disease or death due to any cause, whichever occurs first.
Measured: Baseline up to PD/die, about 20 months
Overall survival (OS)
The time from enrollment to the time of death from any cause.
Measured: Baseline up to die, about 46 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study startJan 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent / Metastatic Nasopharyngeal CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198531
- Sponsor's protocol ID
- TQB2858-Ib-01
- Status last verified
- Jan 2022
- First submitted
- 19 Jan 2022
- Last updated
- 21 Jan 2022
- 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 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Clinical Study to Evaluate the Safety and Efficacy of TQB2858 Injection to the Subjects With Recurrent/Metastatic Nasopharyngeal Cancer
- ClinicalTrials.gov ID
- NCT05198531
- Acronym / sponsor ID
- TQB2858-Ib-01
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 20 Jan 2022 (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 study is a single-arm, randomized, open-label, multi-cohort Phase Ib clinical trial. The experimental drug is TQB2858 Injection. The trial was divided into 3 cohorts. Cohort 1 included patients with advanced nasopharyngeal carcinoma who had previously failed platinum-based chemotherapy and immune checkpoint inhibitors (programmed cell death protein 1 (PD-1)/ Programmed death-ligand 1 (PD-L1), etc.). Cohorts 2 and 3 were randomized into patients with advanced, untreated nasopharyngeal carcinoma who had not received prior systemic therapy. A total of 60-90 subjects are required.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB2858 Injection combining with other drugs | Experimental | Drug: TQB2858 Injection, Drug: Anlotinib Hydrochloride Capsule, Drug: Gemcitabine hydrochloride injection, Drug: Cisplatin InjectionCombination 1 is TQB2858 Injection and Anlotinib Hydrochloride Capsules. Combination 2 is TQB2858 Injection, Gemcitabine Hydrochloride Injection and Cisplatin Injection for 4-6 cycles of induction chemotherapy, then using TQB2858 Injection and Anlotinib Hydrochloride Capsules for maintenance treatment. Combination 3 is TQB2858 Injection, Gemcitabine Hydrochloride Injection, Cisplatin Injection and Anlotinib Hydrochloride Capsules for 4-6 cycles of induction chemotherapy, then using TQB2858 Injection and Anlotinib Hydrochloride Capsules for maintenance treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 1 Voluntarily joined the study and provide written informed consent and authorization permitting release of Protected Health Information.
- 2 Male or female patient ≥18 and ≤75 years of age, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy ≥12 weeks.
- 3 Histologically or cytologically proven diagnosis of nasopharyngeal cancer (NPC), Stage IVb or not amenable for or local treatment (based on 2017, the 8th edition of the American Joint Committee on Cancer (AJCC) staging system of tumor-node-metastasis (TNM) of nasopharyngeal cancer).
- 4 Subject meets one of the following criteria:
- 5 Have at least 1 measurable disease defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Key exclusion criteria (39 listed)
- 1 Complicated disease and history:
- 2 Tumor-related symptoms and treatment:
- 2 Research Treatment Related:
- 4 History of participating in other anti-tumor clinical trials in the previous 4 weeks;
- 5 Other damage to the safety of patients or other situations affecting patients to complete the study, assessed by investigators.
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 |
|---|---|---|
| TQB2858 InjectionTQB2858 Injection, a bifunctional fusion protein against Programmed death ligand 1 (PD-LI) and transforming growth factor-β (TGF-β). TQB2858 Injection blocks the PD-1/PD-L1 pathway and neutralizes TGF-β in the tumor microenvironment. | Drug | TQB2858 Injection combining with other drugs |
| Anlotinib Hydrochloride CapsuleAnlotinib hydrochloride is a muti-target tyrosine kinase inhibitor. | Drug | TQB2858 Injection combining with other drugs |
| Gemcitabine hydrochloride injectionGemcitabine hydrochloride, cell cycle-specific antimetabolites, mainly acting on tumor cells in the DNA synthesis phase (S phase cell). Under certain conditions, it can prevent the progression from G1 phase to S phase. | Drug | TQB2858 Injection combining with other drugs |
| Cisplatin InjectionAfter cisplatin enters cells, it reacts with DNA to form cross-links between two points or two strands in DNA, thereby inhibiting DNA replication and transcription, resulting in DNA breaks and miscoding. | Drug | TQB2858 Injection combining with other drugs |
Primary outcome
Adverse event rate
Time frame: Baseline up to PD/die, about 20 months
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
5 secondary outcomes
Objective Response Rate(ORR)
Time frame: Baseline to CR/PR, about 16 months
Progression-free survival (PFS)
Time frame: Baseline to PD/die, about 20 months
Disease Control rate (DCR)
Time frame: Baseline to CR/PR/SD, about 16 months
Duration of Overall Response (DOR)
Time frame: Baseline up to PD/die, about 20 months
Overall survival (OS)
Time frame: Baseline up to die, about 46 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
Related trials for Recurrent / Metastatic Nasopharyngeal Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Active, not recruitingPhase 2/3
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma
Not yet recruitingPhase 2
Becotatug Vedotin Plus Gemcitabine and a PD-1 Inhibitor in Recurrent or Metastatic Nasopharyngeal Carcinoma
Nasopharyngeal Carcinoma (NPC)
Active, not recruitingPhase 3
A Phase III Study of YL201 in Recurrent or Metastatic Nasopharyngeal Carcinoma (TAISHAN-301)
Nasopharyngeal Carcinoma
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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TQB2858 Injection, Anlotinib Hydrochloride Capsule and Gemcitabine hydrochloride injection in people with Recurrent / Metastatic Nasopharyngeal Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 7 sites 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 16 inclusion and 39 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 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Li Zhang, Master (13902282893, zhangli6@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event rate (time frame: Baseline up to PD/die, about 20 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 21 Jan 2022.