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Esophageal Squamous Cell CarcinomaPhase 2NCT05636150

A Phase II Clinical Study of Fruquintinib Combined With S-1 for Advanced Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Fruquintinib in Combination with S-1 in people with Esophageal Squamous Cell Carcinoma, run by Peking Union Medical College Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Investigators conduct the clinical trial to further explore the efficacy and safety of Fruquintinib combined with S-1 in treating recurrent or metastatic esophageal squamous cell carcinoma after the failure of conventional treatments. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Fruquintinib in Combination with S-1
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
30 Mar 2022to 30 Aug 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients, age:≥18 years old
  • Imageology diagnosed with refractory or metastatic esophageal squamous cell carcinoma
  • Disease progression after the last dose of the first-line therapy (with immunotherapy, without fluoropyrimidine)
  • At least one measurable lesion (RECIST1.1)
  • Good performance status Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 2
  • Life expectancy of more than 12 weeks
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  • The test value for bone marrow, liver and renal function evaluation within 7 days prior to first dosing should meet requirements
  • Negative of blood pregnancy test within 7 days prior to first dosing for fertile female patients. Fertile female and male patients agree to use effective contraceptive methods during the study and within 6 months post to the last dose, such as double barrier contraception, condoms, oral or injection contraceptives, intrauterine devices, abstinence, etc. All female patients will be considered fertile unless the female patient has natural menopause or has undergone artificial menopause or sterilization (hysterectomy, bilateral appendage resection);
  • Signed informed consent

Who cannot join

  • Absolute neutrophil count (ANC) <1.5×109/L, platelet count <75×109/L, and hemoglobin <9g/dL
  • Serum total bilirubin >1.5× the upper limit of normal (ULN)
  • Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >2.5×ULN
  • Creatinine > 1.5 × ULN or creatinine clearance <50 mL/min
  • Activated partial thromboplastin time (APTT)> 1.5 × ULN
  • The investigators determined clinically significant severe electrolyte abnormalities.
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  • Proteinuria ≥ 2+ (1.0g/24hr)
  • Drug uncontrollable hypertension, defined as systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg
  • The patients have active ulcer of stomach and duodenum, ulcerative colitis and other digestive tract diseases or unresectable tumors with active bleeding, or other conditions that may cause gastrointestinal bleeding and perforation, as judged by investigators; or the existence of gastrointestinal perforation or gastrointestinal fistula uncured post to previous surgical treatment
  • Patients with evidence or history of propensity to hemorrhage within 2 months prior to first dosing, regardless of severity(such as melena, hematemesis, hemoptysis, bloody stools）
  • Arterial thrombosis or deep venous thrombosis within 6 months prior to first dosing, or thromboembolic events
  • Cardiovascular diseases of significant clinical significance, including, but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass grafting within 6 months prior to first dosing, congestive heart failure with New York Heart Association (NYHA) grade ≥ 2; Left ventricular ejection fraction (LVEF) < 50%
  • Uncontrolled malignant pleural effusion, ascites or pericardial effusion
  • Previous treatment with anti-vascular endothelial growth factor receptor (VEGFR) inhibitors
  • A history of other malignancies within 5 years prior to inclusion, except for cervical carcinoma in situ, basal or squamous cell skin cancer
  • Distal metastasis to brain
  • History of clinically significant hepatic disease, including, but not limited to, known hepatitis B virus (HBV) infection with HBV DNA positive (copies ≥1×104/ml); known hepatitis C virus infection with HCV RNA positive
  • Women who are pregnant or lactating
  • Patients considered unsuitable for inclusion in this study by the investigator
  • Patients considered a serious mental or mental abnormality

Trial locations and contacts

1 site in 1 country.

Zhao Lin, MD contact

69158753 ext. 010

wz20010727@aliyun.com

Li Ningning contact

13718886921

China1 site, 1 recruiting

  • Peking Union Medical College Hospital

    Beijing

    Zhao Lin, MD

    Recruiting

Other trials in China

About this study

Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of Fuquinitinib Combined With S-1 in the Treatment of Patients With Advanced Esophageal Squamous Cell Carcinoma

Investigators conduct the clinical trial to further explore the efficacy and safety of Fruquintinib combined with S-1 in treating recurrent or metastatic esophageal squamous cell carcinoma after the failure of conventional treatments.

Read the detailed description

Esophageal cancer is one of the most common malignant tumor and esophageal squamous cell carcinoma is the main pathological type of esophageal carcinoma in China. Among patients with advanced or metastatic esophageal squamous cell carcinoma, the addition of immunotherapy to chemotherapy, compared with placebo and chemotherapy, significantly improved overall survival and progression-free survival.Treatment of recurrent or metastatic esophageal squamous cell carcinoma is usually poor. New treatments were needed. Fruquintinib is an orally antiangiogenic agents, which target VEGFR1/2/3. A combination of Fruquintinib and s-1 for advanced or metastatic esophageal squamous cell carcinoma could be a novel therapy. Therefore, investigators initialize this phase II study to explore the safety of fruquintinib and S-1 combination treatment in ESCC patients with after failure in 1st-line immunotherapy.

Being tested
Fruquintinib in Combination with S-1
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fruquintinib in Combination with S-1Drug

    Cohort A: Fruquintinib 3 mg QD, oral dosing, 2 weeks on/1 weeks off+ S-1 40-60mg/time bid po d1-14 q3w.

    Cohort B: Fruquintinib 4 mg QD, oral dosing, 2 weeks on/1 weeks off+ S-1 40-60mg/time bid po d1-14 q3w.

    Cohort C: Fruquintinib 5 mg QD, oral dosing, 2 weeks on/1 weeks off+ S-1 40-60mg/time bid po d1-14 q3w.

    Patients will be treated until disease progression, death, unacceptable toxicity, loss of follow-up, withdrawal of consent or other conditions meet the end of treatment criteria.

Study groups in NCT05636150
Study groupRoleWhat they receive
Fruquintinib plus S-1ExperimentalCohort A: Fruquintinib 3 mg QD, oral dosing, 2 weeks on/1 weeks off+ S-1 40-60mg/time bid po d1-14 q3w. Cohort B: Fruquintinib 4 mg QD, oral dosing, 2 weeks on/1 weeks off+ S-1 40-60mg/time bid po d1-14 q3w. Cohort C: Fruquintinib 5 mg QD, oral dosing, 2 weeks on/1 weeks off+ S-1 40-60mg/time bid po d1-14 q3w.
Receives: Drug: Fruquintinib in Combination with S-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS)

    PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause.

    Measured: From date of first dose of study drug until disease progression, withdrawal of consent, death (up to approximately 1 year)

Secondary outcomes (3)

  1. Overall survival (OS)

    Measured: Baseline to measured date of death from any cause (up to approximately 1 year)

  2. Objective response rate (ORR)

    Tumor assessment will be performed using radiography method every 6 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1

    Measured: from treatment up to progressive disease or EOT due to any cause up to 1 year

  3. Disease control rate (DCR)

    Tumor assessment will be performed using radiography method every 6 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1

    Measured: from treatment up to progressive disease or EOT due to any cause up to 1 year

Timeline

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

  1. First posted5 Dec 2022
  2. Study start30 Mar 2022
  3. Primary completion30 Mar 2024 (estimated)
  4. Study completion30 Aug 2024 (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
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05636150
Sponsor's protocol ID
2021-013-CH07 IIT-EC
Status last verified
Dec 2022
First submitted
23 Nov 2022
Last updated
5 Dec 2022
Results posted
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 in Combination with S-1 in people with Esophageal Squamous Cell Carcinoma, run by Peking Union Medical College 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 9 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: status not confirmed, as of the sponsor's last update on 5 Dec 2022. 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?

Contact Zhao Lin, MD (69158753 ext. 010, wz20010727@aliyun.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 first dose of study drug until disease progression, withdrawal of consent, death (up to approximately 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 NCT05636150.

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 5 Dec 2022.

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