Gastrointestinal Neuroendocrine Pancreatic TumorPhase 2NCT06505395
A Trial to Assess Efficacy, Safety, Pharmacokinetics of Octreotide Subcutaneous Injection in Patients With Gastroentero-pancreatic Neuroendocrine Tumor (GEP-NET)
A Phase 2 study testing SYHX2008 injection and Sandostatin LAR@ in people with Gastrointestinal Neuroendocrine Pancreatic Tumor, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to compare the effectiveness, safety, pharmacokinetics (PK) of SYHX2008 vs Octreotide Microspheres (Sandostatin LAR@) in patients with advanced, well-differentiated GEP-NET. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neuroendocrine Pancreatic Tumor
- What is being tested?
- SYHX2008 injection and Sandostatin LAR@
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2024to 1 Aug 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient ≥18 years old;
- Histologically confirmed, advanced GEP-NET;
- At least 1 measurable, somatostatin receptor-positive lesion according to RECIST 1.1;
- Previous treatment with ≤2 systemic antitumor drugs;
- Patients who do not have liver metastasis, with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and alkaline phosphatase (ALP) levels ≤ 2.5 times the upper limit of normal (ULN) ; and who do have liver metastasis, with ALT and AST ≤ 5 times ULN; Serum total bilirubin <1.5 times the ULN; absolute neutrophil count (ANC) of ≥1.5×10^9/L, platelet count of ≥90×10^9/L, and hemoglobin ≥9 g/dL; or International Normalized Ratio (INR) ≤1.5 ULN and activated partial thromboplastin time (APTT) ≤1.5 ULN;
- ECOG performance status of 0 to 1
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- Have expected survival of more than 3 months;
- Adequately understand the study and voluntarily sign the Informed Consent Form;
- Females patients with reproductive potential must agree to use an effective contraceptive method, for example, intrauterine devices, birth control medicine or condoms, during the study and within 3 months after study treatment discontinuation; or serum pregnancy tests negative and must be non-lactating participants; or males should agree contraception during the study and for within 3 months after study treatment discontinuation.
Who cannot join
- Uncontrolled or severe diarrhea with significant dehydration;
- Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection;
- Anti-tumor therapy received within 4 weeks prior to the initiation of the investigational treatment, for example mammalian target of rapamycin (mTOR) inhibitors or multi-target tyrosine kinase inhibitors (TKI); or short-acting octreotide acetate was received subcutaneously or intravenously within 1 weeks prior to the initiation of the investigational treatment;
- Interferon was received within 4 weeks prior to the initiation of the investigational treatment; or chemotherapy was received within 4 weeks prior to the initiation of the investigational treatment; or transarterial chemoembolization was received within 12 months prior to screening; or previously received peptide receptor radionuclide therapy (PRRT) at any time; or received radiation therapy, anti-tumor traditional Chinese medicine treatment, hepatic artery intervention embolization, liver metastasis cryoablation or radiofrequency ablation, and other systemic anti-tumor drug treatments within 4 weeks prior to the initiation of the investigational treatment; or had participated in other clinical trials within 30 days prior to screening
- Surgery (except biopsy) within 28 days prior to the initiation of investigational treatment or unhealed surgical incision;
- Glycated hemoglobin (HbA1c) > 8.5%;
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- Patients have symptomatic cholelithiasis or a history of symptomatic cholelithiasis at screening, but with no performed surgery treatment;
- Patients with active brain metastases or cancerous meningitis meet any of the following criteria: a) Patients with prior brain metastases, imaging within 4 weeks prior to the first use of investigational drug show progression of the original lesion, or new brain metastases; b) Clinical symptoms associated with central nervous system metastasis did not recovery to baseline; c) Use cortisols, radiotherapy and other drugs to control the symptoms of central nervous system metastasis within 4 weeks before the first use of the investigational drug;
- The adverse reactions of previous antitumor therapy have not returned to ≤ grade 1 according to CTCAE V5.0 (except that the investigators evaluate no safety risk, such as hair loss, grade 2 peripheral neuropathy or dysfunction);
- Any clinically significant uncontrolled neurological, gastrointestinal, renal (serum creatinine > 1.5 ULN), pulmonary, or other significant disease requiring exclusion assessed in the opinion of the Investigator;
- Patients had hepatitis B virus (HBV) infection with HBV DNA positive (copies ≥1×10^4/ml or ≥2000 IU/ml); known Hepatitis C antibodies positive and HCV RNA higher than the lower detection limit ; or human immunodeficiency virus (HIV) positive, treponema pallidum antibody positive;.
- A history of allergy to any excipient of the investigational drug or any similar chemical structure to the investigational drug;
- Patients had any severe or uncontrolled disease, including: 1) poor blood pressure control (systolic ≥160 mmHg or diastolic ≥100 mmHg);2) grade I or higher myocardial ischemia or myocardial infarction, symptomatic or poorly controlled arrhythmia, or congenital long QT syndrome (including QTcF ≥450ms for males, QTcF ≥470ms for females), or ≥ Grade 2 congestive heart failure [NYHA classification]; 3) serious infections that are not under control (oral or intravenous systemic anti-infection therapy is required for 2 weeks before the first use of the investigational drug, except for uncomplicated urinary tract infections and upper respiratory tract infections);4) previous or current severe bleeding (>30ml of bleeding within 3 months), hemoptysis (>5ml of fresh blood within 4 weeks), or thromboembolic events (including transient ischemic attacks) within 12 months;
- Other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions are inappropriate for the use of the investigational product or affect interpretation of study results.
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
Chinese PLA General Hosptial
Beijing, Beijing Municipality, 100853
Jianming Xu, M.D, 010-66947176, Jianmingxu2014@163.com
Clinical Trials Information Group officer, 86-0311-69085587, ctr-contact@cspc.cn
About this study
Official title: A Phase Ⅱ Randomized, Parallel-group, Open-label, Active-controlled Trial to Assess the Efficacy, Safety and Pharmacokinetics of the Long-acting Octreotide Subcutaneous Injection (SYHX2008) Versus Octreotide Microspheres (Sandostatin LAR@) in Patients With GEP-NET
The purpose of this study is to compare the effectiveness, safety, pharmacokinetics (PK) of SYHX2008 vs Octreotide Microspheres (Sandostatin LAR@) in patients with advanced, well-differentiated GEP-NET.
Read the detailed description
This is a Phase II, open-label randomized study to assess the PK, efficacy, and safety of SYHX2008 in adult patients with well-differentiated GEP-NET. Patients will be randomized to SYHX2008 cohort or Octreotide Microspheres cohort (Sandostatin LAR@).
- Being tested
- SYHX2008 injection, Sandostatin LAR@
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYHX2008 injectionDrug
The patients will accept SYHX2008 injection by subcutaneous administration every cycle.
Sandostatin LAR@Drug
The patients will accept Sandostatin LAR@ by intra-muscular administration every cycle.
| Study group | Role | What they receive |
|---|---|---|
| SYHX2008 injection | Experimental | Not described Receives: Drug: SYHX2008 injection |
| Octreotide Microspheres cohort (Sandostatin LAR@) | Active comparator | Not described Receives: Drug: Sandostatin LAR@ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC)
PFS is defined as time from the date of randomization to the date of the first documented disease progression as per RECIST 1.1 or death due to any cause (whichever occurs first)
Measured: Up to 1 years following the last patient enrolled
Secondary outcomes (8)
Overall survival (OS)
The time from the date of randomization to the date of death due to any cause
Measured: Up to 1 years following the last patient enrolled
PFS as assessed by local Investigators
PFS as assessed by local Investigators
Measured: Up to 1 years following the last patient enrolled
Overall response rate(ORR)
The proportion of patients with best overall response of complete response (CR) or partial response (PR), according to RECIST 1.1
Measured: Up to 1 years following the last patient enrolled
Disease control rate (DCR)
The proportion of patients with a best overall response of CR, PR or stable disease (SD), according to RECIST 1.1
Measured: Up to 1 years following the last patient enrolled
Duration of response (DOR)
The time from the date of the first documented response of CR or PR to the date of the first documented progression or death due to underlying cancer, according to RECIST 1.1
Measured: Up to 1 years following the last patient enrolled
Time to Tomor Progression(TTP)
TTP is defined as time from the date of randomization to the date of the first documented disease progression as per RECIST 1.1
Measured: Up to 1 years following the last patient enrolled
Control of cancer-like symptoms (diarrhea and/or flushing)
Assess the total occurrences of diarrhea and/or flushing ( cancer-like symptoms): Evaluate every 8 weeks (±3 days) for the first 12 months following the initial dosage, then every 12 weeks (±7 days). This assessment is based on the total instances of diarrhea and/or flushing episodes within the 7 days preceding the assessment visit.
Measured: Up to 1 years following the last patient enrolled
Incidence of treatment-emergent adverse events
Incidence of treatment-emergent adverse events
Measured: Up to 1 years following the last patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start30 Jul 2024
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Neuroendocrine Pancreatic TumorStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianming Xu, M.D, Study chair, The First Medical Center, Chinese People's Liberation Army General Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505395
- Sponsor's protocol ID
- SYHX2008-004
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 26 Aug 2024
- 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 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅱ Randomized, Parallel-group, Open-label, Active-controlled Trial to Assess the Efficacy, Safety and Pharmacokinetics of the Long-acting Octreotide Subcutaneous Injection (SYHX2008) Versus Octreotide Microspheres (Sandostatin LAR@) in Patients With GEP-NET
- ClinicalTrials.gov ID
- NCT06505395
- Acronym / sponsor ID
- SYHX2008-004
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 17 Jul 2024 (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 purpose of this study is to compare the effectiveness, safety, pharmacokinetics (PK) of SYHX2008 vs Octreotide Microspheres (Sandostatin LAR@) in patients with advanced, well-differentiated GEP-NET.
Detailed description
This is a Phase II, open-label randomized study to assess the PK, efficacy, and safety of SYHX2008 in adult patients with well-differentiated GEP-NET. Patients will be randomized to SYHX2008 cohort or Octreotide Microspheres cohort (Sandostatin LAR@).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYHX2008 injection | Experimental | Drug: SYHX2008 injection |
| Octreotide Microspheres cohort (Sandostatin LAR@) | Active comparator | Drug: Sandostatin LAR@ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female patient ≥18 years old;
- Histologically confirmed, advanced GEP-NET;
- At least 1 measurable, somatostatin receptor-positive lesion according to RECIST 1.1;
- Previous treatment with ≤2 systemic antitumor drugs;
- Patients who do not have liver metastasis, with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and alkaline phosphatase (ALP) levels ≤ 2.5 times the upper limit of normal (ULN) ; and who do have liver metastasis, with ALT and AST ≤ 5 times ULN; Serum total bilirubin <1.5 times the ULN; absolute neutrophil count (ANC) of ≥1.5×10^9/L, platelet count of ≥90×10^9/L, and hemoglobin ≥9 g/dL; or International Normalized Ratio (INR) ≤1.5 ULN and activated partial thromboplastin time (APTT) ≤1.5 ULN;
Key exclusion criteria (14 listed)
- Uncontrolled or severe diarrhea with significant dehydration;
- Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection;
- Anti-tumor therapy received within 4 weeks prior to the initiation of the investigational treatment, for example mammalian target of rapamycin (mTOR) inhibitors or multi-target tyrosine kinase inhibitors (TKI); or short-acting octreotide acetate was received subcutaneously or intravenously within 1 weeks prior to the initiation of the investigational treatment;
- Interferon was received within 4 weeks prior to the initiation of the investigational treatment; or chemotherapy was received within 4 weeks prior to the initiation of the investigational treatment; or transarterial chemoembolization was received within 12 months prior to screening; or previously received peptide receptor radionuclide therapy (PRRT) at any time; or received radiation therapy, anti-tumor traditional Chinese medicine treatment, hepatic artery intervention embolization, liver metastasis cryoablation or radiofrequency ablation, and other systemic anti-tumor drug treatments within 4 weeks prior to the initiation of the investigational treatment; or had participated in other clinical trials within 30 days prior to screening
- Surgery (except biopsy) within 28 days prior to the initiation of investigational treatment or unhealed surgical incision;
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 |
|---|---|---|
| SYHX2008 injectionThe patients will accept SYHX2008 injection by subcutaneous administration every cycle. | Drug | SYHX2008 injection |
| Sandostatin LAR@The patients will accept Sandostatin LAR@ by intra-muscular administration every cycle. | Drug | Octreotide Microspheres cohort (Sandostatin LAR@) |
Primary outcome
Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC)
Time frame: Up to 1 years following the last patient enrolled
PFS is defined as time from the date of randomization to the date of the first documented disease progression as per RECIST 1.1 or death due to any cause (whichever occurs first)
8 secondary outcomes
Overall survival (OS)
Time frame: Up to 1 years following the last patient enrolled
PFS as assessed by local Investigators
Time frame: Up to 1 years following the last patient enrolled
Overall response rate(ORR)
Time frame: Up to 1 years following the last patient enrolled
Disease control rate (DCR)
Time frame: Up to 1 years following the last patient enrolled
Duration of response (DOR)
Time frame: Up to 1 years following the last patient enrolled
Time to Tomor Progression(TTP)
Time frame: Up to 1 years following the last patient enrolled
Control of cancer-like symptoms (diarrhea and/or flushing)
Time frame: Up to 1 years following the last patient enrolled
Incidence of treatment-emergent adverse events
Time frame: Up to 1 years following the last patient enrolled
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 26 Aug 2024.
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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.
Jianming Xu, M.D study chair
The First Medical Center, Chinese People's Liberation Army General Hospital, Beijing, China
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 SYHX2008 injection and Sandostatin LAR@ in people with Gastrointestinal Neuroendocrine Pancreatic Tumor, 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 9 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: looking for participants now, as of the sponsor's last update on 26 Aug 2024. 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 Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC) (time frame: Up to 1 years following the last patient enrolled). 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 26 Aug 2024.