Stomach NeoplasmsPhase 2NCT05795296
Efficacy and Safety of Fruquintinib With Sintilimab as First-line Therapy in Gastric Cancer
A Phase 2 study testing Fruquintinib and Sintilimab in people with Stomach Neoplasms, run by RenJi Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to explore the efficacy and safety in patients with gastric adenocarcinoma or adenocarcinoma of esophagogastric junction. The main questions it aims to answer are: Does this therapy have a promising efficacy? Does this therapy have a manageable toxicity? Participants will receive… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Fruquintinib and Sintilimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 31 Aug 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological confirmed advanced, recurrent, of metastatic gastric adenocarcinoma or adenocarcinoma of esophagogastric junction;
- ECOG PS: 0-2;
- Adequate hepatic, renal, heart, and hematologic functions;
- At least one measurable lesion (according to RECIST1.1);
- Haven't received any systematic treatment for the cancer involved;
- Expected survival > 12 weeks;
- Contraception until 6 months after the study termination;
- Signed informed consent.
Who cannot join
- Her-2-positive gastric cancer, or exposed to any immune checkpoint inhibitor;
- Participated in another study;
- Immunodeficiency;
- Received allograft；
- Unmanageable hypertension, diabetes, or coronary disease;
- Have difficulty in taking medicine, or active bleeding;
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- Pulmonary tuberculosis, or interstitial lung disease that needs steroid therapy;
- Infection of HIV, HBV, HCV, or other unmanageable infection;
- Other malignant tumor history;
- Allergic to the test drug;
- Other diseases which will affect the results of this study;
- Received resection of stomach;
- Taking anti-tumor traditional Chinese Medicine;
- Severe active bleeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study of Fruquintinib in Combination With Sintilimab as a First-line Therapy in Gastric Adenocarcinoma/Adenocarcinoma of Esophagogastric Junction
The goal of this clinical trial is to explore the efficacy and safety in patients with gastric adenocarcinoma or adenocarcinoma of esophagogastric junction. The main questions it aims to answer are:
- Does this therapy have a promising efficacy?
- Does this therapy have a manageable toxicity? Participants will receive fruquintinib plus sintilimab as first-line therapy for gastric cancer.
- Conditions
- Stomach Neoplasms
- Being tested
- Fruquintinib, Sintilimab
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FruquintinibDrug
Fruquintinib: 5mg po, d1-d14, q3w
SintilimabDrug
Sintilimab: 200mg ivgtt, d1, q3w
| Study group | Role | What they receive |
|---|---|---|
| Fruquintinib+Sintilimab | Experimental | Fruquintinib: 5mg po, d1-d14, q3w
Sintilimab: 200mg ivgtt, d1, q3w Receives: Drug: Fruquintinib; Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The proportion of patients with complete response or partial response, using RECIST v 1.1.
Measured: 12 months
Secondary outcomes (4)
Progression-Free Survival (PFS)
Time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
Measured: 12 months
Overall survival (OS)
Time from randomization to death from any cause.
Measured: 12 months
Disease Control Rate (DCR)
The proportion of patients with complete response, partial response or stable disease, using RECIST v 1.1.
Measured: 12 months
Adverse Events
Adverse event assessed according to CTCAE v5.0.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Dec 2022
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingchun Xu, RenJi Hospital
- Investigators
- Shuiping Tu, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795296
- Sponsor's protocol ID
- HMPL-013-SH-GC-101
- Status last verified
- Aug 2023
- First submitted
- 21 Mar 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Fruquintinib in Combination With Sintilimab as a First-line Therapy in Gastric Adenocarcinoma/Adenocarcinoma of Esophagogastric Junction
- ClinicalTrials.gov ID
- NCT05795296
- Acronym / sponsor ID
- HMPL-013-SH-GC-101
- Conditions
- Stomach Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 3 Apr 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 goal of this clinical trial is to explore the efficacy and safety in patients with gastric adenocarcinoma or adenocarcinoma of esophagogastric junction. The main questions it aims to answer are:
- Does this therapy have a promising efficacy?
- Does this therapy have a manageable toxicity? Participants will receive fruquintinib plus sintilimab as first-line therapy for gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fruquintinib+Sintilimab | Experimental | Drug: Fruquintinib, Drug: SintilimabFruquintinib: 5mg po, d1-d14, q3w Sintilimab: 200mg ivgtt, d1, q3w |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histological or cytological confirmed advanced, recurrent, of metastatic gastric adenocarcinoma or adenocarcinoma of esophagogastric junction;
- ECOG PS: 0-2;
- Adequate hepatic, renal, heart, and hematologic functions;
- At least one measurable lesion (according to RECIST1.1);
- Haven't received any systematic treatment for the cancer involved;
Key exclusion criteria (14 listed)
- Her-2-positive gastric cancer, or exposed to any immune checkpoint inhibitor;
- Participated in another study;
- Immunodeficiency;
- Received allograft；
- Unmanageable hypertension, diabetes, or coronary disease;
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 |
|---|---|---|
| FruquintinibFruquintinib: 5mg po, d1-d14, q3w | Drug | Fruquintinib+Sintilimab |
| SintilimabSintilimab: 200mg ivgtt, d1, q3w | Drug | Fruquintinib+Sintilimab |
Primary outcome
Objective response rate (ORR)
Time frame: 12 months
The proportion of patients with complete response or partial response, using RECIST v 1.1.
4 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 12 months
Overall survival (OS)
Time frame: 12 months
Disease Control Rate (DCR)
Time frame: 12 months
Adverse Events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
Related trials for Stomach Neoplasms
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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.
Shuiping Tu 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 Fruquintinib and Sintilimab in people with Stomach Neoplasms, 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 8 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: status not confirmed, as of the sponsor's last update on 30 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 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 30 Aug 2023.