Gastric CancerPhase 2NCT06094868
Clinical Study of Fruquintinib Combined With Sintilimab and XELOX Regimen in the Treatment of Advanced Cancer
A Phase 2 study testing Fruquintinib in people with Gastric Cancer, run by Second Affiliated Hospital of Nanchang University.
Trial summary
To explore the efficacy and safety of Fruquintinib combined with Sintilimab and XELOX in the first-line treatment of unresectable advanced metastatic gastric or gastroesophageal junction adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Fruquintinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Oct 2026
- 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
- Have fully understood the study and voluntarily signed the informed consent;
- Histologically and/or cytologically confirmed unresectable advanced gastric or gastroesophageal junction adenocarcinoma;
- Age 18-75 (including 18 and 75 years old);
- ECOG physical condition 0-1 score;
- Locally advanced unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma that has not received systemic therapy before (Note: Time from the end of previous (new) adjuvant chemotherapy/adjuvant radiotherapy to disease recurrence \> 6 months);
- For local lesions (non-target lesions), the time from the end of palliative treatment to random enrollment was > 2 weeks;
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- At least one measurable or evaluable lesion according to RECIST v1.1 criteria;
- Negative Her2;
- Expected survival ≥3 months;
- The functions of vital organs during the first 14 days of enrollment met the following requirements:
- Absolute neutrophil count ≥1.5×109/L;
- Platelet ≥80×109/L;
- Hemoglobin ≥90g/L;
- Total bilirubin < 1.5 ULN;
- ALT and AST < 2.5 ULN (< 5 ULN in patients with liver metastasis);
- Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr)≥60ml/min;
- endogenous creatinine clearance > 50ml/min;
- Female subjects of childbearing age or male subjects whose sexual partner is a female of childbearing age should take effective contraceptive measures throughout the treatment period and 6 months after the treatment period;
- Good compliance, cooperate with follow-up.
Who cannot join
- Failure to comply with the study protocol or study procedure;
- Previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors or previous treatment with immune checkpoint inhibitors;
- Have had other malignancies within the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
- Known presence of symptomatic central nervous system metastasis and/or cancerous meningitis. Participants with previously treated BMS may participate in the trial if their condition is stable (no evidence of radiographic progression at least 4 weeks prior to initial administration of the trial treatment), repeated radiographic studies confirm no evidence of new BMS or enlargement of the original BMS, and no steroid therapy is required at least 14 days prior to initial administration of the trial treatment. This exception does not include cancerous meningitis, which should be excluded regardless of whether it is clinically stable;
- Had autoimmune disease or history of autoimmune disease within 4 weeks before enrollment;
- Previously received allogeneic bone marrow transplantation or organ transplantation;
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- Uncontrolled malignant ascites (defined as ascites that cannot be controlled by diuretics or puncture as determined by the researcher);
- Severe cardiovascular disease, including unstable angina pectoris or myocardial infarction, occurs within 6 months before the start of study treatment;
- Subjects who are allergic to the investigational drug or any of its adjuncts;
- Participated in other domestic unapproved or unmarketed drug clinical trials and accepted the corresponding experimental drug treatment within 4 weeks before enrollment;
- Had a major surgical procedure (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study therapy or expected to require major surgery during study therapy.
- International Standardized Ratio (INR) \> 1.5 or partially activated prothrombin time (APTT) \> 1.5×ULN;
- The investigator identified clinically significant electrolyte abnormalities;
- Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg;
- Poorly controlled diabetes mellitus was present before enrollment (fasting glucose concentration ≥CTCAE level 2 after formal treatment);
- Had any disease or condition prior to enrollment that affected drug absorption, or the patient could not take fuquintinib orally;
- Gastrointestinal diseases such as active ulcer of stomach and duodenum, ulcerative colitis, or active bleeding of unresectosed tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by researchers before enrollment;
- Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding within 3 months \> 30 mL, hematemesis, stool, stool blood), hemoptysis (within 4 weeks \> 5 mL of fresh blood) or had a thromboembolic event (including stroke events and/or transient ischemic attacks) within 12 months;
- Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh grade B or more severe cirrhosis;
- A history of intestinal obstruction or the following diseases: inflammatory bowel disease or extensive enterectomy (partial resection of the colon or extensive resection of the small intestine with chronic diarrhea), Crohn's disease, ulcerative colitis;
- Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Grades for Congestive Heart Failure \> Level 2; Ventricular arrhythmias requiring medical treatment; LVEF (Left ventricular Ejection Fraction) \< 50%;
- Active or uncontrolled severe infection (≥CTCAE v5.0 grade 2 infection);
- Known human immunodeficiency virus (HIV) infection. Known history of clinically significant liver disease, including viral hepatitis [Known hepatitis B virus (HBV) carriers must rule out active HBV infection, i.e., positive HBV DNA (\>1×104 copies /mL or \> 2000 IU/ml); known hepatitis C virus infection (HCV) and HCV RNA positive (\>1×103 copies /mL)];
- Unmitigated toxicity higher than CTCAE v5.0 grade 1 due to any previous anticancer therapy, excluding alopecia, lymphocytopenia, and oxaliplatin grade ≤2 neurotoxicity;
- Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
- Received blood transfusion therapy, blood products and hematopoietic factors, such as albumin and granulocyte colony-stimulating factor (G-CSF), within 14 days before enrollment;
- Urine routine indicated urinary protein ≥2+, and 24-hour urinary protein volume > 1.0g;
- Complications require long-term treatment with immunosuppressants or systemic or local use of immunosuppressive corticosteroids (\> 10mg/ day prednisone or other therapeutic hormone);
- Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, which, in the investigator's judgment, reasonably suspects that the patient has a medical condition or condition that is not suitable for the use of the investigational drug (such as having seizures and requiring treatment), or which would affect the interpretation of the study results or place the patient at high risk。
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single-arm, Open-label, Multicenter Phase II Clinical Study of Fruquintinib Combined With Sintilimab and XELOX in the First-line Treatment of Advanced Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
To explore the efficacy and safety of Fruquintinib combined with Sintilimab and XELOX in the first-line treatment of unresectable advanced metastatic gastric or gastroesophageal junction adenocarcinoma.
Read the detailed description
To explore the progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety of Fruquintinib combined with Sintilimab and XELOX in the first-line treatment of unresectable advanced metastatic gastric or gastroesophageal junctional adenocarcinoma.
- Conditions
- Gastric Cancer
- Being tested
- Fruquintinib
- 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
Also called Sintilimab, Oxaliplatin, Capecitabine
Fruquintinib: 4mg, QD, PO, D1-D14, Q3W; Sintilimab: weight < 60kg, 3mg/kg; weight≥60kg, 200 mg; I.V.， D1，Q3W；. XELOX regimen: Oxaliplatin: 130 mg/m2, ivgtt, D1, Q3W; Capecitabine: 1000 mg/m2, bid, D1-D14, Q3W; After 6 cycles of treatment, chemotherapy was given and maintenance treatment was given with Fruquintinib combined with Sintilimab. The above medication regimen can be adjusted according to the adverse reaction tolerance of the subjects.
- Maintenance of treatment until disease progression, or intolerable toxic reactions, or other conditions determined by the investigator
| Study group | Role | What they receive |
|---|---|---|
| Fruquintinib in combination with Sintilimab and XELOX | Experimental | Fruquintinib: 4mg, QD, PO, D1-D14, Q3W; Sintilimab: weight < 60kg, 3mg/kg; weight≥60kg, 200 mg; I.V.， D1，Q3W； XELOX regimen: oxaliplatin: 130 mg/m2, ivgtt, D1, Q3W; Capecitabine: 1000 mg/m2, bid, D1-D14, Q3W; After 6 cycles of treatment, chemotherapy was given and maintenance treatment was given with fuquitinib combined with sindillizumab. The above medication regimen can be adjusted according to the adverse reaction tolerance of the subjects.
* Maintenance of treatment until disease progression, or intolerable toxic reactions, or other conditions determined by the investigator Receives: Drug: Fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
The time from enrollment to disease progression or death Outcome 1
Title:
Progression-free survival (PFS)
Description:
The time from enrollment to disease progression or death
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes (4)
Objective response rate (ORR)
Proportion of patients with complete or partial response
Measured: During treatment
Disease control rate (DCR)
Proportion of patients assessed as having a complete response, partial response, or stable disease
Measured: During treatment
Overall survival (OS)
Patients were enrolled until their death from any cause
Measured: Through study completion, an average of 1 year
Security
Safety was evaluated by adverse reactions
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang 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
- 45 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Wang, Second Affiliated Hospital of Nanchang University
- Investigators
- Wang Hua, Director, Principal investigator, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094868
- Sponsor's protocol ID
- HMPL-013-E1-GC002
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 23 Oct 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 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, Multicenter Phase II Clinical Study of Fruquintinib Combined With Sintilimab and XELOX in the First-line Treatment of Advanced Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06094868
- Acronym / sponsor ID
- HMPL-013-E1-GC002
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 23 Oct 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.
To explore the efficacy and safety of Fruquintinib combined with Sintilimab and XELOX in the first-line treatment of unresectable advanced metastatic gastric or gastroesophageal junction adenocarcinoma.
Detailed description
To explore the progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety of Fruquintinib combined with Sintilimab and XELOX in the first-line treatment of unresectable advanced metastatic gastric or gastroesophageal junctional adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fruquintinib in combination with Sintilimab and XELOX | Experimental | Drug: FruquintinibFruquintinib: 4mg, QD, PO, D1-D14, Q3W; Sintilimab: weight < 60kg, 3mg/kg; weight≥60kg, 200 mg; I.V.， D1，Q3W； XELOX regimen: oxaliplatin: 130 mg/m2, ivgtt, D1, Q3W; Capecitabine: 1000 mg/m2, bid, D1-D14, Q3W; After 6 cycles of treatment, chemotherapy was given and maintenance treatment was given with fuquitinib combined with sindillizumab. The above medication regimen can be adjusted according to the adverse reaction tolerance of the subjects. * Maintenance of treatment until disease progression, or intolerable toxic reactions, or other conditions determined by the investigator |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Have fully understood the study and voluntarily signed the informed consent;
- Histologically and/or cytologically confirmed unresectable advanced gastric or gastroesophageal junction adenocarcinoma;
- Age 18-75 (including 18 and 75 years old);
- ECOG physical condition 0-1 score;
- Locally advanced unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma that has not received systemic therapy before (Note: Time from the end of previous (new) adjuvant chemotherapy/adjuvant radiotherapy to disease recurrence \> 6 months);
Key exclusion criteria (29 listed)
- Failure to comply with the study protocol or study procedure;
- Previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors or previous treatment with immune checkpoint inhibitors;
- Have had other malignancies within the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
- Known presence of symptomatic central nervous system metastasis and/or cancerous meningitis. Participants with previously treated BMS may participate in the trial if their condition is stable (no evidence of radiographic progression at least 4 weeks prior to initial administration of the trial treatment), repeated radiographic studies confirm no evidence of new BMS or enlargement of the original BMS, and no steroid therapy is required at least 14 days prior to initial administration of the trial treatment. This exception does not include cancerous meningitis, which should be excluded regardless of whether it is clinically stable;
- Had autoimmune disease or history of autoimmune disease within 4 weeks before enrollment;
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 |
|---|---|---|
| FruquintinibAlso: Sintilimab, Oxaliplatin, CapecitabineFruquintinib: 4mg, QD, PO, D1-D14, Q3W; Sintilimab: weight < 60kg, 3mg/kg; weight≥60kg, 200 mg; I.V.， D1，Q3W；. XELOX regimen: Oxaliplatin: 130 mg/m2, ivgtt, D1, Q3W; Capecitabine: 1000 mg/m2, bid, D1-D14, Q3W; After 6 cycles of treatment, chemotherapy was given and maintenance treatment was given with Fruquintinib combined with Sintilimab. The above medication regimen can be adjusted according to the adverse reaction tolerance of the subjects. * Maintenance of treatment until disease progression, or intolerable toxic reactions, or other conditions determined by the investigator | Drug | Fruquintinib in combination with Sintilimab and XELOX |
Primary outcome
Progression-free survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
The time from enrollment to disease progression or death Outcome 1 Title: Progression-free survival (PFS) Description: The time from enrollment to disease progression or death
4 secondary outcomes
Objective response rate (ORR)
Time frame: During treatment
Disease control rate (DCR)
Time frame: During treatment
Overall survival (OS)
Time frame: Through study completion, an average of 1 year
Security
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 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.
Wang Hua, Director principal investigator
Second Affiliated Hospital of Nanchang University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fruquintinib in people with Gastric Cancer, run by Second Affiliated Hospital of Nanchang University.
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 19 inclusion and 29 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 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Wang Hua, Director (13667098735, 13667098735@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: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 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 23 Oct 2023.