ESCCPhase 2NCT06531291
Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation
A Phase 2 study testing Surufatinib, Serplulimab and standard chemotherapy in people with ESCC and Biliary Tract Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
Currently, there are no standard treatment and relevant exploration for solid tumors patients with NED. The study aims to explore the efficacy and safety of surufatinib combined with serplulimab and standard chemotherapy in the treatment ofadvanced solid tumors with NED, in order to provide a new treatment option for… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ESCC, Biliary Tract Cancer, Gastric Cancer
- What is being tested?
- Surufatinib, Serplulimab and standard chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2024to 9 Aug 2027
- 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
- Histopathologically confirmed locally advanced or metastatic unresectable ESCC, BTC, PC or GC with an abnormal NED or NE phenotype (without neuroendocrine morphologic features and positive immunohistochemical expression of at least one neuroendocrine marker (CgA, Syn));
- Have at least one measurable lesion according to RECIST v1.1;
- ECOG performance status: 0-1;
- No previous systemic therapy;
- Urine protein< ++ . If Urine protein ≥ ++ ,the amount of urine protein in 24 hours ≤1.0g;
- Expected survival time \> 3 months;
Who cannot join
- Have uncontrolled hypertension, defined as systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mm Hg, while under anti-hypertension treatment;
- With active bleeding or bleeding tendency;
- Severe history of cardiovascular and cerebrovascular diseases;
- Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection.
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
Renji hospital
Shanghai, Shanghai Municipality, 200127
Liwei Wang, Dr, +86 16621086648, lwwang2013@163.com
About this study
Official title: Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation: A Single-arm, Multi-cohort, Open-label, Single-center, Prospective, Exploratory Clinical Study
Currently, there are no standard treatment and relevant exploration for solid tumors patients with NED. The study aims to explore the efficacy and safety of surufatinib combined with serplulimab and standard chemotherapy in the treatment ofadvanced solid tumors with NED, in order to provide a new treatment option for advanced solid tumors patients with NED.
Read the detailed description
This is a single-arm, multi-cohort, open-label, single-center, prospective, exploratory clinical study. We planned to enroll 80 patients who would receive surufatinib plus tislelizumab until disease progression, intolerance, or withdrawal of consent. The study aims to explore the efficacy and safety of surufatinib combined with serplulimab and standard chemotherapy in the treatment of advanced solid tumors with NED, in order to provide a new treatment option for advanced solid tumors patients with NED.
- Conditions
- ESCC, Biliary Tract Cancer, Gastric Cancer, Pancreas Cancer
- Being tested
- Surufatinib, Serplulimab, standard chemotherapy
- Keywords
- surufatinib, Neuroendocrine Differentiation
- Medical subject headings
- Biliary Tract Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurufatinibDrug
250 mg, po, qd, q3w
SerplulimabDrug
200 mg, iv, d1, q3w
standard chemotherapyDrug
Decided by PI
| Study group | Role | What they receive |
|---|---|---|
| Surufatinib + serplulimab + standard chemotherapy | Experimental | Not described Receives: Drug: Surufatinib; Drug: Serplulimab; Drug: standard chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
time from first-dose to the first documented disease progression or death
Measured: approximately 1 years
Secondary outcomes (2)
Objective response rate (ORR)
the proportion of patients with complete response or partial response, using RESIST v1.1
Measured: approximately 1 years
Disease Control Rate (DCR)
the proportion of patients with complete response, partial response or stable disease, using RESIST v1.1
Measured: approximately 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start10 Aug 2024 (estimated)
- Primary completion9 Aug 2027 (estimated)
- Study completion9 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESCCStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, liwei wang, RenJi Hospital
- Investigators
- Liwei Wang, Doctorate, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531291
- Sponsor's protocol ID
- CPOGCNED-14
- Status last verified
- Jul 2024
- First submitted
- 28 Jul 2024
- Last updated
- 31 Jul 2024
- 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 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation: A Single-arm, Multi-cohort, Open-label, Single-center, Prospective, Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT06531291
- Acronym / sponsor ID
- CPOGCNED-14
- Conditions
- ESCC, Biliary Tract Cancer, Gastric Cancer, Pancreas Cancer
- Keywords
- surufatinib, Neuroendocrine Differentiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 10 Aug 2024 (estimated)
- Primary completion
- 9 Aug 2027 (estimated)
- Study completion
- 9 Aug 2027 (estimated)
- First posted
- 31 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.
Currently, there are no standard treatment and relevant exploration for solid tumors patients with NED. The study aims to explore the efficacy and safety of surufatinib combined with serplulimab and standard chemotherapy in the treatment ofadvanced solid tumors with NED, in order to provide a new treatment option for advanced solid tumors patients with NED.
Detailed description
This is a single-arm, multi-cohort, open-label, single-center, prospective, exploratory clinical study. We planned to enroll 80 patients who would receive surufatinib plus tislelizumab until disease progression, intolerance, or withdrawal of consent. The study aims to explore the efficacy and safety of surufatinib combined with serplulimab and standard chemotherapy in the treatment of advanced solid tumors with NED, in order to provide a new treatment option for advanced solid tumors patients with NED.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surufatinib + serplulimab + standard chemotherapy | Experimental | Drug: Surufatinib, Drug: Serplulimab, Drug: standard chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histopathologically confirmed locally advanced or metastatic unresectable ESCC, BTC, PC or GC with an abnormal NED or NE phenotype (without neuroendocrine morphologic features and positive immunohistochemical expression of at least one neuroendocrine marker (CgA, Syn));
- Have at least one measurable lesion according to RECIST v1.1;
- ECOG performance status: 0-1;
- No previous systemic therapy;
- Urine protein< ++ . If Urine protein ≥ ++ ,the amount of urine protein in 24 hours ≤1.0g;
Key exclusion criteria (4 listed)
- Have uncontrolled hypertension, defined as systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mm Hg, while under anti-hypertension treatment;
- With active bleeding or bleeding tendency;
- Severe history of cardiovascular and cerebrovascular diseases;
- Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection.
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 |
|---|---|---|
| Surufatinib250 mg, po, qd, q3w | Drug | Surufatinib + serplulimab + standard chemotherapy |
| Serplulimab200 mg, iv, d1, q3w | Drug | Surufatinib + serplulimab + standard chemotherapy |
| standard chemotherapyDecided by PI | Drug | Surufatinib + serplulimab + standard chemotherapy |
Primary outcome
Progression-Free Survival (PFS)
Time frame: approximately 1 years
time from first-dose to the first documented disease progression or death
2 secondary outcomes
Objective response rate (ORR)
Time frame: approximately 1 years
Disease Control Rate (DCR)
Time frame: approximately 1 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 31 Jul 2024.
- 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.
Liwei Wang, Doctorate principal investigator
RenJi 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 Surufatinib, Serplulimab and standard chemotherapy in people with ESCC and Biliary Tract Cancer, run by RenJi Hospital 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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 31 Jul 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 Liwei Wang, Doctorate (+86 16621086648, lwwang2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: approximately 1 years). 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 31 Jul 2024.