Metastatic Gastroesophageal Junction AdenocarcinomaPhase 1/2NCT06329973
Fruquintinib in Combination With Sintilimab and CAPEOX as First-line Treatment for G/GEJ Cancer
A Phase 1/2 study testing Fruquintinib in combination with Sintilimab and CAPEOX in people with Metastatic Gastroesophageal Junction Adenocarcinoma, run by Henan Cancer Hospital at 1 site in China.
Trial summary
Based on the current status and progress in the treatment of gastric cancer, our center prospectively designed a first-line comprehensive treatment plan for unresectable or postoperative recurrent advanced gastric/gastroesophageal conjoint adenocarcinoma, fruquintinib + sintilimab + oxaliplatin + Capecitabine… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Fruquintinib in combination with Sintilimab and CAPEOX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2024to 28 Jun 2028
- Phase
- Phase 1/2
- 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
- Subjects aged 18-75 years (including 18 and 75 years);
- Understand the research procedure and content, and voluntarily sign a written informed consent;
- Incurable advanced/recurrent gastric or gastroesophageal junction adenocarcinoma with histopathological and/or cytological confirmation of HER2-negative or HER2 status unknown;
- There is at least one measurable lesion according to RECIST 1.1 criteria;
- No previous treatment with VEGFR-targeting drugs or PD-1/PD-L1 monoclonal antibody. Patients who had received platinum or paclitaxel or fluorouracil adjuvant chemotherapy after surgery and recurred more than 6 months after the end of chemotherapy without grade 2 toxicity or higher could be enrolled.
- Physical condition score (ECOG PS score) : 0-1 score;
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- Expected survival ≥3 months;
- The main organs function well;That is, the relevant check indicators within 14 days before randomization meet the following requirements:
- Hemoglobin ≥ 90 g/L (no transfusion within 14 days); Neutrophil count > 1.5×109/L; Platelet count ≥ 100×109/L; Total bilirubin ≤ 1.5×ULN (upper limit of normal); Serum glutamic pyruvic aminotransferase (ALT) or serum glutamic oxalacetic aminotransferase (AST) ≤ 2.5×ULN; If there is liver metastasis, ALT or AST ≤ 5×ULN; Endogenous creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula); Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ 50%; Thyroid function index: thyroid stimulating hormone (TSH), free thyroxine (FT3/FT4) in the normal range;
- Weight of more than 40 kg (including 40 kg), or BMI > 18.5
- Women who are fertile must have a negative urine or serum pregnancy test within 7 days prior to randomization and must consent to use highly effective contraception during the study period and for at least 120 days after the last administration of fruquintinib and sintilimab and for at least 180 days after the last administration of chemotherapy (Appendix 9);
- Men who are not sterilized must consent to use highly effective contraception during the study period and for at least 120 days after the last administration of fruquintinib and sintilimab and for at least 180 days after the last administration of chemotherapy (Appendix 9).
Who cannot join
- Patients with other malignant tumors in the past or at the same time, but have been cured of early tumors, including skin basal cell carcinoma, cervical carcinoma in situ, stage I lung cancer, stage I colorectal cancer and other tumors that researchers judge will not affect the patient's life in the short term can be excluded;
- Participated in other drug clinical trials within four weeks;
- have multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
- Have a history of bleeding, any bleeding event with a severity rating of CTCAE5.0 or higher occurring within 4 weeks prior to screening;
- Patients with known central nervous system metastasis or history of central nervous system metastasis before screening. For patients with clinically suspected CNS metastasis, CT or MRI examination must be performed within 28 days before enrollment to rule out CNS metastasis.
- Patients with hypertension who are not well controlled by single antihypertensive medication (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90mmHg); Patients with history of unstable angina pectoris; Patients with newly diagnosed angina pectoris or myocardial infarction within 3 months prior to screening; Arrhythmias (including QTcF: ≥450 ms in men and ≥470 ms in women) requiring long-term use of antiarrhythmic drugs and New York Heart Association grade ≥II cardiac insufficiency;
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- long-term unhealed wounds or incomplete healing fractures;
- Imaging shows that the tumor has invaded important blood vessels, or the investigator determines that the patient's tumor is highly likely to invade important blood vessels during treatment and cause fatal massive bleeding;
- Patients with abnormal coagulation function and bleeding tendency (14 days before randomization must meet: INR in the normal range without the use of anticoagulants, or no clinically significant abnormalities); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogs; Low doses of warfarin (1 mg orally, once daily) or low doses of aspirin (up to 100 mg daily) are permitted for prophylactic purposes if INR ≤ 1.5;
- Occurrence of arteriovenous thrombosis events within 6 months prior to screening, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis (except venous thrombosis caused by intravenous catheterization in previous chemotherapy and cured by investigators), pulmonary embolism, etc.;
- Urine routine indicated urinary protein ≥++ and confirmed 24-hour urinary protein quantity > 1.0g;
- Have used immunotargeted therapy drugs;
- Have a history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
- Patients with infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other patients requiring corticosteroids;
- A history of serious chronic autoimmune diseases, such as systemic lupus erythematosus; History of ulcerative enteritis, Crohn's disease and other inflammatory bowel diseases, irritable bowel syndrome and other chronic diarrheal diseases; A history of sarcoidosis or tuberculosis; History of active hepatitis B, hepatitis C and HIV infection; Well controlled non-severe immune diseases such as dermatitis, arthritis, psoriasis, etc. can be included. Hepatitis B virus drops <1000copy/ml could be included in the group.
- Patients with hypersensitivity to human or murine monoclonal antibodies;
- Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders;
- pleural effusion or abdominal effusion with clinical symptoms requiring clinical intervention;
- Patients who do not follow medical advice, do not use drugs according to regulations, or have incomplete data that can affect the evaluation of efficacy or safety;
- In the judgment of the investigator, there is a serious concomitant disease that endangers the patient's safety or interferes with the patient's completion of the 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
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Xiaobing Chen, +8613937100233
About this study
Official title: A Single-arm, Open-label, Multicenter, Phase Ib/II Study to Evaluate the Safety and Efficacy of Fruquintinib in Combination With Sintilimab and CAPEOX as 1L Treatment for Advanced Unresectable or Metastatic G/GEJ Cancer (FUNCTION Research)
Based on the current status and progress in the treatment of gastric cancer, our center prospectively designed a first-line comprehensive treatment plan for unresectable or postoperative recurrent advanced gastric/gastroesophageal conjoint adenocarcinoma, fruquintinib + sintilimab + oxaliplatin + Capecitabine (CAPEOX), which utilizes the tumor immunomodulation and vascular normalization effects of fruquintinib. While improving the effective perfusion of intravenous chemotherapy with CAPEOX regimen, further combining with PD-1 monoclonal antibody to regulate the immunosuppressive microenvironment and reactivate the anti-tumor immune response of the body. An exploratory dose-climbing trial was designed to evaluate the clinical efficacy and safety of fruquintinib in combination with Sintilimab and CAPEOX in clinical practice. At the same time, changes in genome, pathology and immune microenvironment of tumor-related tissues before and after treatment were observed, and molecular markers related to curative effect were screened to explore the molecular mechanism affecting the curative effect of combination therapy, and further enrichment of therapeutic advantage groups to improve the surgical conversion rate laid the foundation for future large-scale clinical studies
- Being tested
- Fruquintinib in combination with Sintilimab and CAPEOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruquintinib in combination with Sintilimab and CAPEOXDrug
Different doses of fruquintinib combined with sintilimab and CAPEOX
| Study group | Role | What they receive |
|---|---|---|
| Fruquintinib in combination with Sintilimab and CAPEOX | Experimental | Not described Receives: Drug: Fruquintinib in combination with Sintilimab and CAPEOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
It refers to the proportion of patients whose tumors have shrunk to a certain extent for a certain period of time, including CR and PR cases
Measured: From date of enrollment until the date of the end of the study, assessed up to 48 months
Maximum tolerated dose
Refers to the maximum tolerated dose of the whole group
Measured: Within the first 21 days of treatment
Secondary outcomes (7)
Overall Survival
Refers to the date from admission to death from any cause
Measured: From date of enrollment until the date of death, assessed up to 48 months
Progression Free Survival
Refers to the date from admission to the first onset of disease progression or death from any cause, whichever comes first
Measured: From date of enrollment until the date of first documented progression, assessed up to 48 months
Disease Control Rate
Refers to the percentage of confirmed complete response, partial response, and stable disease cases in patients evaluated for efficacy
Measured: From date of enrollment until the date of the end of the study, assessed up to 48 months
Duration of Response
Refers to the date of first documented response (Complete Response or Partial Response) until the date of first documented disease progression or death from any cause, whichever occurs first.
Measured: From date of enrollment until the date of the end of the study, assessed up to 48 months
Surgical conversion rate
Refers to the proportion of patients with initially unresectable disease who achieve R0/R1 resection after therapy
Measured: From date of enrollment until the date of the end of the study, assessed up to 48 months
Adverse events
Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0
Measured: From first dose of study drug to 30 days after last dose or the initiation of a new anticancer therapy, whichever occurred first, up to the end of study.
Identification of molecular biomarkers predictive of efficacy
To investigate associations between baseline and on-treatment molecular biomarkers (e.g., expression of PD-L1 and Claudin 18.2, EBEV, MMR, and other factors) with clinical outcomes
Measured: From date of enrollment until the date of the end of the study, assessed up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start28 Feb 2024
- Primary completion28 Jun 2026 (estimated)
- Study completion28 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Xiaobing Chen, Study chair, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329973
- Sponsor's protocol ID
- 2023-237
- Status last verified
- Jun 2025
- First submitted
- 24 Jan 2024
- Last updated
- 17 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be shared for secondary analysis under controlled access.
Publications
Chen B, Zhao J, Lv H, Xu W, Wang J, Nie C, He Y, Zhang B, Huang J, Liu Y, Ma F, Zhang H, Guo Y, Liu Y, Li P, Chen X, Chen X. Single-arm, open-label, multicentre phase 1b/2 study to evaluate the safety and efficacy of fruquintinib combined with sintilimab and CAPEOX as a first-line treatment for advanced gastric or gastroesophageal junction adenocarcinoma (FUNCTION study): a study protocol. BMJ Open. 2025 Sep 26;15(9):e100241. doi: 10.1136/bmjopen-2025-100241.
PubMed 41005780
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, Multicenter, Phase Ib/II Study to Evaluate the Safety and Efficacy of Fruquintinib in Combination With Sintilimab and CAPEOX as 1L Treatment for Advanced Unresectable or Metastatic G/GEJ Cancer (FUNCTION Research)
- ClinicalTrials.gov ID
- NCT06329973
- Acronym / sponsor ID
- 2023-237
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 28 Jun 2026 (estimated)
- Study completion
- 28 Jun 2028 (estimated)
- First posted
- 26 Mar 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.
Based on the current status and progress in the treatment of gastric cancer, our center prospectively designed a first-line comprehensive treatment plan for unresectable or postoperative recurrent advanced gastric/gastroesophageal conjoint adenocarcinoma, fruquintinib + sintilimab + oxaliplatin + Capecitabine (CAPEOX), which utilizes the tumor immunomodulation and vascular normalization effects of fruquintinib. While improving the effective perfusion of intravenous chemotherapy with CAPEOX regimen, further combining with PD-1 monoclonal antibody to regulate the immunosuppressive microenvironment and reactivate the anti-tumor immune response of the body. An exploratory dose-climbing trial was designed to evaluate the clinical efficacy and safety of fruquintinib in combination with Sintilimab and CAPEOX in clinical practice. At the same time, changes in genome, pathology and immune microenvironment of tumor-related tissues before and after treatment were observed, and molecular markers related to curative effect were screened to explore the molecular mechanism affecting the curative effect of combination therapy, and further enrichment of therapeutic advantage groups to improve the surgical conversion rate laid the foundation for future large-scale clinical studies
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 CAPEOX | Experimental | Drug: Fruquintinib in combination with Sintilimab and CAPEOX |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects aged 18-75 years (including 18 and 75 years);
- Understand the research procedure and content, and voluntarily sign a written informed consent;
- Incurable advanced/recurrent gastric or gastroesophageal junction adenocarcinoma with histopathological and/or cytological confirmation of HER2-negative or HER2 status unknown;
- There is at least one measurable lesion according to RECIST 1.1 criteria;
- No previous treatment with VEGFR-targeting drugs or PD-1/PD-L1 monoclonal antibody. Patients who had received platinum or paclitaxel or fluorouracil adjuvant chemotherapy after surgery and recurred more than 6 months after the end of chemotherapy without grade 2 toxicity or higher could be enrolled.
Key exclusion criteria (20 listed)
- Patients with other malignant tumors in the past or at the same time, but have been cured of early tumors, including skin basal cell carcinoma, cervical carcinoma in situ, stage I lung cancer, stage I colorectal cancer and other tumors that researchers judge will not affect the patient's life in the short term can be excluded;
- Participated in other drug clinical trials within four weeks;
- have multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
- Have a history of bleeding, any bleeding event with a severity rating of CTCAE5.0 or higher occurring within 4 weeks prior to screening;
- Patients with known central nervous system metastasis or history of central nervous system metastasis before screening. For patients with clinically suspected CNS metastasis, CT or MRI examination must be performed within 28 days before enrollment to rule out CNS metastasis.
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 in combination with Sintilimab and CAPEOXDifferent doses of fruquintinib combined with sintilimab and CAPEOX | Drug | Fruquintinib in combination with Sintilimab and CAPEOX |
Primary outcome
Objective response rate
Time frame: From date of enrollment until the date of the end of the study, assessed up to 48 months
It refers to the proportion of patients whose tumors have shrunk to a certain extent for a certain period of time, including CR and PR cases
Maximum tolerated dose
Time frame: Within the first 21 days of treatment
Refers to the maximum tolerated dose of the whole group
7 secondary outcomes
Overall Survival
Time frame: From date of enrollment until the date of death, assessed up to 48 months
Progression Free Survival
Time frame: From date of enrollment until the date of first documented progression, assessed up to 48 months
Disease Control Rate
Time frame: From date of enrollment until the date of the end of the study, assessed up to 48 months
Duration of Response
Time frame: From date of enrollment until the date of the end of the study, assessed up to 48 months
Surgical conversion rate
Time frame: From date of enrollment until the date of the end of the study, assessed up to 48 months
Adverse events
Time frame: From first dose of study drug to 30 days after last dose or the initiation of a new anticancer therapy, whichever occurred first, up to the end of study.
Identification of molecular biomarkers predictive of efficacy
Time frame: From date of enrollment until the date of the end of the study, assessed up to 48 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 17 Jul 2025.
- Derived from this study: PubMed 41005780Chen B, Zhao J, Lv H, Xu W, Wang J, Nie C, He Y, Zhang B, Huang J, Liu Y, Ma F, Zhang H, Guo Y, Liu Y, Li P, Chen X, Chen X. Single-arm, open-label, multicentre phase 1b/2 study to evaluate the safety and efficacy of fruquintinib combined with sintilimab and CAPEOX as a first-line treatment for advanced gastric or gastroesophageal junction adenocarcinoma (FUNCTION study): a study protocol. BMJ Open. 2025 Sep 26;15(9):e100241. doi: 10.1136/bmjopen-2025-100241.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data will be shared for secondary analysis under controlled access.
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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.
Xiaobing Chen study chair
Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fruquintinib in combination with Sintilimab and CAPEOX in people with Metastatic Gastroesophageal Junction Adenocarcinoma, run by Henan Cancer 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 12 inclusion and 20 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 17 Jul 2025. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Xiaobing Chen (+8613937100233, zlyychenxb0807@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: From date of enrollment until the date of the end of the study, assessed up to 48 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06329973, which also lists 1 linked publication.
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 17 Jul 2025.