Gastric AdenocarcinomaPhase 2NCT05235906
A Phase II Clinical Study of Surufatinib Combined With Sintilimab in the Treatment of Advanced Gastric Cancer
A Phase 2 study testing Surufatinib+Sintilimab in people with Gastric Adenocarcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
The efficacy and safety of the use of Surufatinib in combination with Sintilimab. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Adenocarcinoma
- What is being tested?
- Surufatinib+Sintilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 16 Aug 2022to 31 Mar 2025
- 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
- Patients must have the ability to understand and voluntarily sign informed consent;
- Age: 18-75 years old;
- Patients have histologically or cytologically confirmed advanced or recurrent gastric or gastroesophageal junction adenocarcinoma;
- NO previous therapy for advanced/metastatic disease of GC/GEJ and CPS≥1;
- Patients have measurable disease as defined by RECIST 1.1 as determined by investigator;
- Eastern Cooperative Group (ECOG) performance status of 0 to 2;
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- Has adequate organ function;
- Expected survival period ≥ 3 months;
- Patients who not received a blood transfusion within 7 days of registration;
- Patients have recovered adverse events associated with chemotherapy, radiation and surgical operation as pretreatment to Grade 1 or lower with CTCAE v5.0 excluding stable symptoms (eg alopecia, peripheral sensory neuropathy, skin hyperpigmentation, dysgeusia etc.).
- Patients capable of taking oral medication;
- Female of childbearing potential who are negative in a pregnancy test within 7 days before enrollment. Both male and female patients should agree to use an adequate method of contraception (total abstinence, an intrauterine device or hormone releasing system, an contraceptive implant and an oral contraceptive) starting with the first dose of study therapy through 6 months after the last dose of study therapy. Duration will be determined when the subject is assigned to treatment.
Who cannot join
- Patients who received prior anticancer treatment within 14 days (or 5 times the half-life time, whichever is shorter) or any investigational agent within 28 days prior to the first dose of study drugs.
- Patients who have undergone surgical treatment and radiotherapy with in 2 weeks before enrollment.
- Patients with a history of prior treatment with Lenvatinib or any anti-programmed death 1 (anti-PD-1), anti-programmed ligand death 1 (anti-PD-L1), or anti-programmed ligand death 2 (anti-PD-L2 agent).
- Patients with symptomatic brain metastasis.
- Patients with hypertension that is difficult to control (systolic blood pressure ≥150 mmHg and diastolic blood pressure ≥100 mmHg) despite treatment with several hypotensive agents.
- Those who have received live vaccination within 4 weeks before the start of treatment.
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- Patients with active hepatitis.
- Patients with a history of human immunodeficiency virus (HIV).
- Patients were judged unsuitable as subject of this trial by investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer center of SunYat-sen University
Guangzhou, Guangdong, 510060
Dongsheng Zhang, MD,PhD, 86-2087343795, zhangdsh@sysucc.org.cn
About this study
Official title: An Open-label, Single Center, Phase II Study of Surufatinib Combined With Sintilimab in Patients With Advanced Adenocarcinoma of the Gastric or Gastrooesophageal Junction Adneocarcinoma Cancer
The efficacy and safety of the use of Surufatinib in combination with Sintilimab.
- Conditions
- Gastric Adenocarcinoma
- Being tested
- Surufatinib+Sintilimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surufatinib+SintilimabDrug
Surufatinib at a dose of 250mg Qd, with humanized anti-PD-1 monoclonal antibody Sintilimab injected intravenously 200mg per 3 weeks until disease progresses or unacceptable tolerability occurs.
| Study group | Role | What they receive |
|---|---|---|
| Surufatinib + Sintilimab | Experimental | Not described Receives: Drug: Surufatinib+Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST
Measured: up to 12 months
Secondary outcomes (3)
Disease control rate (DCR)
Measured: up to 12 months
Progression-free survival (PFS)
Measured: up to 12 months
Overall survival (OS)
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start16 Aug 2022
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong sheng Zhang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235906
- Sponsor's protocol ID
- HMPL-012-SPRING-G104
- Status last verified
- Aug 2023
- First submitted
- 9 Feb 2022
- Last updated
- 9 Aug 2023
- 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 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Center, Phase II Study of Surufatinib Combined With Sintilimab in Patients With Advanced Adenocarcinoma of the Gastric or Gastrooesophageal Junction Adneocarcinoma Cancer
- ClinicalTrials.gov ID
- NCT05235906
- Acronym / sponsor ID
- HMPL-012-SPRING-G104
- Conditions
- Gastric Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 11 Feb 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.
The efficacy and safety of the use of Surufatinib in combination with Sintilimab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surufatinib + Sintilimab | Experimental | Drug: Surufatinib+Sintilimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must have the ability to understand and voluntarily sign informed consent;
- Age: 18-75 years old;
- Patients have histologically or cytologically confirmed advanced or recurrent gastric or gastroesophageal junction adenocarcinoma;
- NO previous therapy for advanced/metastatic disease of GC/GEJ and CPS≥1;
- Patients have measurable disease as defined by RECIST 1.1 as determined by investigator;
Key exclusion criteria (9 listed)
- Patients who received prior anticancer treatment within 14 days (or 5 times the half-life time, whichever is shorter) or any investigational agent within 28 days prior to the first dose of study drugs.
- Patients who have undergone surgical treatment and radiotherapy with in 2 weeks before enrollment.
- Patients with a history of prior treatment with Lenvatinib or any anti-programmed death 1 (anti-PD-1), anti-programmed ligand death 1 (anti-PD-L1), or anti-programmed ligand death 2 (anti-PD-L2 agent).
- Patients with symptomatic brain metastasis.
- Patients with hypertension that is difficult to control (systolic blood pressure ≥150 mmHg and diastolic blood pressure ≥100 mmHg) despite treatment with several hypotensive agents.
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 |
|---|---|---|
| Surufatinib+SintilimabSurufatinib at a dose of 250mg Qd, with humanized anti-PD-1 monoclonal antibody Sintilimab injected intravenously 200mg per 3 weeks until disease progresses or unacceptable tolerability occurs. | Drug | Surufatinib + Sintilimab |
Primary outcome
Objective response rate (ORR)
Time frame: up to 12 months
Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST
3 secondary outcomes
Disease control rate (DCR)
Time frame: up to 12 months
Progression-free survival (PFS)
Time frame: up to 12 months
Overall survival (OS)
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
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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 Surufatinib+Sintilimab in people with Gastric Adenocarcinoma, run by Sun Yat-sen University 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 12 inclusion and 9 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 9 Aug 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?
Contact Dongsheng Zhang, PhD (86-2087343795, zhangdsh@sysucc.org.cn), 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: up to 12 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 9 Aug 2023.