Gastric Cancer/Adenocarcinoma of Esophagogastric JunctionG/GEJ cancerNCT06158919
A Study of PD-1 Inhibitors Combined With Fruquintinib and Chemotherapy in First-line Treatment of HER2-negative Advanced G/GEJ Cancer
A study testing Fruquintinib、Nivolumab、Sintilimab、Oxaliplatin、Teysuno、Capecitabine in people with Gastric Cancer/Adenocarcinoma of Esophagogastric Junction, run by Fudan University at 1 site in China.
Trial summary
This is an open-label, single-arm, single-center clinical study to investigate the safety and efficacy of fuquinitinib combined with PD-1 inhibitors and first-line chemotherapy in the treatment of inoperable HER2-negative advanced GC/GEJC. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer/Adenocarcinoma of Esophagogastric Junction
- What is being tested?
- Fruquintinib、Nivolumab、Sintilimab、Oxaliplatin、Teysuno、Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2023to 20 Nov 2026
- Phase
- Interventional
- 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 80 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;
- 2.18-80 years old (including 18 and 80 years old), male or female;
- 3. Patients with unresectable advanced or metastatic gastric/esophagogastric junction adenocarcinoma confirmed by pathology or histology;
- 4.ECOG physical status 0-1
- 5. Expected survival ≥3 months;
- 6. Have not received any anti-tumor therapy (including chemotherapy, targeted therapy, immunotherapy, etc.) for unresectable advanced or metastatic gastric cancer; If you have received adjuvant therapy after radical gastrectomy of gastric cancer, it is required that the time between the discovery of metastatic disease and the end of the last adjuvant chemotherapy is greater than 6 months);
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- 7. Must have at least one measurable lesion (meet the RECIST v1.1 standard);
- 8. The functions of vital organs meet the following requirements (the use of any blood components and cell growth factors is not allowed within the first 14 days of enrollment) :
- Absolute neutrophil count ≥1.5×109/L, white blood cell ≥3.0×109/L;
- Platelet ≥90×109/L;
- Hemoglobin ≥8g/dL;
- Total bilirubin TBIL≤1.5 times ULN;
- ⑤ALT and AST≤2.5 times ULN;
- ⑥ Urea/urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN (and creatinine clearance (CCr) ≥ 50mL/min);
- ⑦Left ventricular ejection fraction (LVEF) ≥50%;
- ⑧Fridericia Corrected QT Interval (QTcF) <470 milliseconds;
- ⑨INR≤1.5 x ULN, APTT≤1.5 x ULN;
- ⑩Thyroid function, thyroid stimulating hormone (TSH) ≤ upper limit of normal (ULN), if abnormal FT3 and FT4 levels should be examined, FT3 and FT4 levels can be included if normal;
- 9. Premenopausal and postmenopausal women \< Women of 1 year must have a negative serum or urine pregnancy test before treatment.
Who cannot join
- 1. Patients with known HER-2 status (immunohistochemical 3+, or immunohistochemical 2+\&FISH positive);
- 2. Had other malignancies within 5 years prior to admission, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
- 3. Previously received allogeneic bone marrow transplantation or organ transplantation;
- 4. Severe cardiovascular disease, including unstable angina pectoris or myocardial infarction, in the 6 months prior to enrollment;
- 5. Subjects who are allergic to the investigational drug or any of its adjuncts;
- 6. Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg;
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- 7. Had any disease or condition affecting drug absorption before enrollment, or the patient could not take drugs orally;
- 8. Gastrointestinal diseases such as active ulcer of stomach and duodenum, ulcerative colitis, or active bleeding of unexcised tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by researchers before enrollment;
- 9. 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;
- 10. 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%;
- 11. Active or uncontrolled severe infection (≥CTCAE v5.0 grade 2 infection);
- 12. 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);
- 13. The patient has any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; The patient had vitiligo; Those with complete remission of asthma in childhood can be included without any intervention in adulthood; Patients with asthma requiring medical intervention with bronchodilators are not included); Replacement therapy is not considered systemic, and the following patients may be included: have a history of autoimmune related hypothyroidism and are receiving thyroid hormone replacement therapy; Type 1 diabetes can be controlled by insulin therapy.
- 14. Immunosuppressive use of immunosuppressants or systemic hormone therapy within 7 days prior to enrollment for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormone).
- 15. Currently suffering from interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung disease, radiation pneumonia;
- 16. Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
- 17. 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;
- 18. Urine routine indicated urinary protein ≥2+, and 24-hour urinary protein volume ≥1.0g;
- Patients considered inappropriate for inclusion in this study.
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
Fudan University ShangHai Cancer Center
Shanghai, Shanghai Municipality
Chenchen Wang, 13774232040, wccnancy2003@aliyun.com
About this study
Official title: A Phase II Clinical Study of PD-1 Inhibitors Combined With Fruquintinib and Chemotherapy in First-line Treatment of HER2-negative Advanced G/GEJ Cancer
This is an open-label, single-arm, single-center clinical study to investigate the safety and efficacy of fuquinitinib combined with PD-1 inhibitors and first-line chemotherapy in the treatment of inoperable HER2-negative advanced GC/GEJC.
Eligible enrolled patients received 6 cycles of combined treatment with fuquinitinib combined with PD-1 inhibitor and chemotherapy (XELOX/SOX) regimen. Maintenance treatment was fuquinitinib combined with PD-1 inhibitor and Teghio/capecitabine until disease progression or toxicity became intolerable. The longest duration of PD-1 inhibitor treatment is 24 months.
- Being tested
- Fruquintinib、Nivolumab、Sintilimab、Oxaliplatin、Teysuno、Capecitabine
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruquintinib、Nivolumab、Sintilimab、Oxaliplatin、Teysuno、CapecitabineDrug
Combined treatment period: A total of 6 cycles of combined treatment Fruquintinib: 4 mg/d, qd po, d1-14, q3w. Nivolumab: 360mg iv.gtt d1, q3w or Sintilimab: 200mg iv.gtt d1, q3w SOX : Oxaliplatin 130mg/m2 iv.gtt d1, Teysuno 40mg/m2 p.o.b.i.d. d1~ 14q3w. Or XELOX regimen: oxaliplatin 130mg/m2 iv.gtt d1 Capecitabine 1000mg/m2 p.o. b.i.d. d1~ 14q3w.
Maintenance treatment period:
Fruquintinib: 4 mg/d, qd po, d1-14, q3w. Nivolumab: 360mg iv.gtt d1, q3w or Sintilimab: 200mg iv.gtt d1, q3w Teysuno 40mg/m2 p.o.b.i.d. d1~14 q3w or Capecitabine 1000mg/m2 p.o.b.i.d. d1~14 q3w.
Maintenance of treatment until disease progression or toxicity becomes intolerable.
| Study group | Role | What they receive |
|---|---|---|
| PD-1 Inhibitors Combined With Fruquintinib and Chemotherapy | Experimental | Combined treatment period: A total of 6 cycles of combined treatment Fruquintinib: 4 mg/d, qd po, d1-14, q3w. Nivolumab: 360mg iv.gtt d1, q3w or Sindilizumab: 200mg iv.gtt d1, q3w SOX: Oxaliplatin 130mg/m2 iv.gtt d1, Teysuno 40mg/m2 p.o.b.i.d. d1~ 14q3w. Or XELOX regimen: oxaliplatin 130mg/m2 iv.gtt d1 Capecitabine 1000mg/m2 p.o. b.i.d. d1~ 14q3w.
Maintenance treatment period:
Fruquintinib: 4 mg/d, qd po, d1-14, q3w. Nivolumab: 360mg iv.gtt d1, q3w or Sindilizumab: 200mg iv.gtt d1, q3w Teysuno 40mg/m2 p.o.b.i.d. d1~14 q3w or Capecitabine 1000mg/m2 p.o.b.i.d. d1~14 q3w.
Maintenance of treatment until disease progression or toxicity becomes intolerable.The longest duration of PD-1 inhibitor treatment is 24 months. Receives: Drug: Fruquintinib、Nivolumab、Sintilimab、Oxaliplatin、Teysuno、Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-free survival
Measured: From date of enrollment until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes (3)
ORR
Objective response rate
Measured: From date of enrollment until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
DCR
disease control rate
Measured: From date of enrollment until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
OS
overall survival
Measured: From date of enrollment until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed 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 posted6 Dec 2023
- Study start20 Nov 2023
- Primary completion20 Nov 2024 (estimated)
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer/Adenocarcinoma of Esophagogastric JunctionStudies of the same condition, open and under way.
- More trials run by Fudan 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaodong Zhu, Fudan University
- Investigators
- Xiaodong Zhu, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158919
- Sponsor's protocol ID
- FDZL-FIX
- Acronym
- G/GEJ cancer
- Status last verified
- Nov 2023
- First submitted
- 28 Nov 2023
- Last updated
- 6 Dec 2023
- 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 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of PD-1 Inhibitors Combined With Fruquintinib and Chemotherapy in First-line Treatment of HER2-negative Advanced G/GEJ Cancer
- ClinicalTrials.gov ID
- NCT06158919
- Acronym / sponsor ID
- G/GEJ cancer / FDZL-FIX
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 20 Nov 2024 (estimated)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 6 Dec 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.
This is an open-label, single-arm, single-center clinical study to investigate the safety and efficacy of fuquinitinib combined with PD-1 inhibitors and first-line chemotherapy in the treatment of inoperable HER2-negative advanced GC/GEJC.
Eligible enrolled patients received 6 cycles of combined treatment with fuquinitinib combined with PD-1 inhibitor and chemotherapy (XELOX/SOX) regimen. Maintenance treatment was fuquinitinib combined with PD-1 inhibitor and Teghio/capecitabine until disease progression or toxicity became intolerable. The longest duration of PD-1 inhibitor treatment is 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-1 Inhibitors Combined With Fruquintinib and Chemotherapy | Experimental | Drug: Fruquintinib、Nivolumab、Sintilimab、Oxaliplatin、Teysuno、CapecitabineCombined treatment period: A total of 6 cycles of combined treatment Fruquintinib: 4 mg/d, qd po, d1-14, q3w. Nivolumab: 360mg iv.gtt d1, q3w or Sindilizumab: 200mg iv.gtt d1, q3w SOX: Oxaliplatin 130mg/m2 iv.gtt d1, Teysuno 40mg/m2 p.o.b.i.d. d1~ 14q3w. Or XELOX regimen: oxaliplatin 130mg/m2 iv.gtt d1 Capecitabine 1000mg/m2 p.o. b.i.d. d1~ 14q3w. Maintenance treatment period: Fruquintinib: 4 mg/d, qd po, d1-14, q3w. Nivolumab: 360mg iv.gtt d1, q3w or Sindilizumab: 200mg iv.gtt d1, q3w Teysuno 40mg/m2 p.o.b.i.d. d1~14 q3w or Capecitabine 1000mg/m2 p.o.b.i.d. d1~14 q3w. Maintenance of treatment until disease progression or toxicity becomes intolerable.The longest duration of PD-1 inhibitor treatment is 24 months. |
Who may qualify
- Ages
- 18 to 80 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;
- 2.18-80 years old (including 18 and 80 years old), male or female;
- 3. Patients with unresectable advanced or metastatic gastric/esophagogastric junction adenocarcinoma confirmed by pathology or histology;
- 4.ECOG physical status 0-1
- 5. Expected survival ≥3 months;
Key exclusion criteria (19 listed)
- 1. Patients with known HER-2 status (immunohistochemical 3+, or immunohistochemical 2+\&FISH positive);
- 2. Had other malignancies within 5 years prior to admission, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
- 3. Previously received allogeneic bone marrow transplantation or organ transplantation;
- 4. Severe cardiovascular disease, including unstable angina pectoris or myocardial infarction, in the 6 months prior to enrollment;
- 5. Subjects who are allergic to the investigational drug or any of its adjuncts;
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 |
|---|---|---|
| Fruquintinib、Nivolumab、Sintilimab、Oxaliplatin、Teysuno、CapecitabineCombined treatment period: A total of 6 cycles of combined treatment Fruquintinib: 4 mg/d, qd po, d1-14, q3w. Nivolumab: 360mg iv.gtt d1, q3w or Sintilimab: 200mg iv.gtt d1, q3w SOX : Oxaliplatin 130mg/m2 iv.gtt d1, Teysuno 40mg/m2 p.o.b.i.d. d1~ 14q3w. Or XELOX regimen: oxaliplatin 130mg/m2 iv.gtt d1 Capecitabine 1000mg/m2 p.o. b.i.d. d1~ 14q3w. Maintenance treatment period: Fruquintinib: 4 mg/d, qd po, d1-14, q3w. Nivolumab: 360mg iv.gtt d1, q3w or Sintilimab: 200mg iv.gtt d1, q3w Teysuno 40mg/m2 p.o.b.i.d. d1~14 q3w or Capecitabine 1000mg/m2 p.o.b.i.d. d1~14 q3w. Maintenance of treatment until disease progression or toxicity becomes intolerable. | Drug | PD-1 Inhibitors Combined With Fruquintinib and Chemotherapy |
Primary outcome
PFS
Time frame: From date of enrollment until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Progression-free survival
3 secondary outcomes
ORR
Time frame: From date of enrollment until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
DCR
Time frame: From date of enrollment until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
OS
Time frame: From date of enrollment until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
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 6 Dec 2023.
- 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.
Xiaodong Zhu principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruquintinib、Nivolumab、Sintilimab、Oxaliplatin、Teysuno、Capecitabine in people with Gastric Cancer/Adenocarcinoma of Esophagogastric Junction, run by Fudan 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 19 inclusion and 19 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 6 Dec 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.
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 Xiaodong Zhu (18017312567, xddr001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From date of enrollment until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 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 6 Dec 2023.