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AzTrials

Stomach NeoplasmsPhase 2NCT05625737

Fruquintinib Combined with Sintilimab As Second-line Therapy for Gastric or Gastro-esophageal Junction Adenocarcinoma

A Phase 2 study testing Fruquintinib and Sintilimab in people with Stomach Neoplasms, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This was a single-arm, prospective study to investigate the efficacy and safety of fruquintinib combined with sintilimab in the second-line treatment of Chinese patients with advanced gastric/GEJ adenocarcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Stomach Neoplasms
What is being tested?
Fruquintinib and Sintilimab
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteChina
Study dates
8 Sep 2022to Sep 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

  • Signed the Informed Consent Form
  • Ages: 18-75 Years (concluding 18 and 75 Years)
  • Pathologically confirmed unresectable advanced gastric/gastroesophageal junction adenocarcinoma
  • Failure to 1st line therapy, completed at least 28 days before enrollment
  • HER2-negative
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
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  • Life expectancy greater than 3 months
  • At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan, larger than 20 mm in diameter by conventional CT scan) according to RECIST1.1
  • Sufficient organ functions as follows (any blood transfusion or cell growth factor use within 14 days before enrollment is not allowed):
  • Absolute Neutrophil Count (ANC) ≥1.5×109/L Platelet Count of ≥175×109/L; Hemoglobin≥90g/L; Total Bilirubin (TBIL) ≤1.5 x ULN; ALT and /or AST<1.5 x ULN; If there is liver metastasis, then ALT and/or AST<3.0 x ULN; Serum Creatinine (SCr) ≤1.5×ULN; Endogenous creatinine clearance rate ≥50ml / min；
  • Man and woman who childbearing potential agrees to use adequate contraception
  • Willingness to provide enough tumor tissues for PD-L1 expression test

Who cannot join

  • Patients could not obey the study protocol.
  • Previous therapy with VEGFR Inhibitor.
  • Other malignancy within 5 years prior to study enrolment, except for cervical carcinoma in situ, basal or squamous cell skin cancer.
  • Known brain or CNS metastases.
  • Patients with any active autoimmune disease or a documented history of autoimmune disease within 4 weeks prior to enrollment.
  • Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
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  • Uncontrolled malignant ascites.
  • Clinically significant cardiovascular diseases, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure, New York Heart Association (NYHA) grade > 2; ventricular arrhythmia requiring drug treatment; LVEF (left ventricular ejection fraction) < 50%.
  • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
  • Participation in another clinical trial with any experimental drug within 4 weeks prior to enrollment.
  • Clinically significant electrolyte abnormalities judged by researchers.
  • Systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg regardless of any antihypertensive drugs.
  • Poorly controlled diabetes before enrollment.
  • Any factors that influence the usage of oral administration and patients cannot take fruquintinib orally.
  • Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI, or other conditions that may cause GI bleeding and perforation as determined by the investigator.
  • Patients with obvious evidence of bleeding tendency or medical history within 3 months before enrollment, hemoptysis or thromboembolism within 12 months.
  • Active infection or serious infection that is uncontrolled by drug (NCI CTCAE v. 5.0 Grade ≥ 2).
  • History of clinically significant hepatic disease, including hepatitis B virus (HBV) infection with HBV DNA positive (copies ≥1×104/ml or >2000IU/ml); known hepatitis C virus infection with HCV RNA positive (copies ≥1×103/ml).
  • Persisting toxicity related to prior therapy (NCI CTCAE v. 5.0 Grade > 1).
  • Pregnant or breastfeeding female patient.
  • Receive blood transfusion, blood products and hematopoietic factors such as albumin and granulocyte colony stimulating factor (G-CSF) within 14 days prior to enrollment.
  • Other severe acute or chronic medical conditions including metabolic disorder, physical examination or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
  • Urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0 g.
  • Use of immunosuppressive medication, or systemic/local immunosuppressive corticosteroids for complication.
  • Patients considered unsuitable for inclusion in this study by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Wuhan Union Hospital, China

    Wuhan, Hubei, 430030

Other trials in China

About this study

Official title: A Single-center, Single-arm, Open-label, Exploratory Study Evaluating Fruquintinib Combined with Sintilimab in Second-line Treatment of Patients with Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma

This was a single-arm, prospective study to investigate the efficacy and safety of fruquintinib combined with sintilimab in the second-line treatment of Chinese patients with advanced gastric/GEJ adenocarcinoma.

Read the detailed description

Patients with adenocarcinoma of the gastro-esophageal junction or the stomach who have documented progression after being treated with a 1st line chemotherapy can be included. All patients will receive a second line therapy with fruquintinib and sintilimab, a checkpoint inhibitor. Clinical and radiographic assessment will be performed regularly. Patients will be treated until disease progression, untolerable toxicity or withdrawal of consent.

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 will be administrated as 4mg orally, once daily for 2 weeks on/1 week off.

  • SintilimabDrug

    Sintilimab will be administrated as 200mg once every 3 weeks.

Study groups in NCT05625737
Study groupRoleWhat they receive
Fruquintinib plus SintilimabExperimentalFruquintinib combined with sintilimab. Fruquintinib: 4 mg/d, qd, po, d1-14, q3w; Sintilimab: 200 mg/d, 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.

  1. Objective Response Rate (ORR)

    ORR is defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.

    Measured: from date of randomization until the date of progressive disease or EOT due to any cause, assessed up to 1 year

Secondary outcomes (5)

  1. Progression-Free Survival (PFS)

    PFS is defined as the time from randomization 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: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year

  2. Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: from date of randomization until the date of death due to any cause, assessed up to 2 years

  3. Disease Control Rate (DCR)

    DCR is defined as the percentage of participants who have a confirmed complete response（CR） or partial response（PR） or stable disease（SD） per RECIST 1.1 as assessed by investigator

    Measured: from date of randomization until the date of progressive disease or EOT due to any cause, assessed up to 1 year

  4. Duration of Response (DoR)

    DoR is defined as the time how long response lasts

    Measured: from date of the first documentation of response to the date of the first documentation of objective tumor progression or death due to any cause, whichever came first, assessed up to 1 year

  5. Adverse Event (AEs)

    Safety 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 the date of first dose to the 30 days post the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2022
  2. Study start8 Sep 2022
  3. Primary completionDec 2024 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

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
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05625737
Sponsor's protocol ID
HMPL-013-CC-GC003
Status last verified
Oct 2023
First submitted
9 Nov 2022
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 25 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 19 Sep 2024. 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: from date of randomization until the date of progressive disease or EOT due to any cause, assessed up to 1 year). 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 NCT05625737.

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 19 Sep 2024.

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