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

NCT05636150 | Unknown Phase 2

• 1 other identifier: 2021-013-CH07 IIT-EC
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (3)

• Overall survival (OS)

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

• Objective response rate (ORR)

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

• Disease control rate (DCR)

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

Study Arms (1)

Fruquintinib plus S-1

EXPERIMENTAL

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.

Drug: Fruquintinib in Combination with S-1

Interventions

Fruquintinib in Combination with S-1 DRUG

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.

Fruquintinib plus S-1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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
• Distal metastasis to brain

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

HMPL-013; S 1 (combination)

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Zhao Lin, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhao Lin, MD

CONTACT

69158753; wz20010727@aliyun.com

Li Ningning

CONTACT

13718886921

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 5, 2022
• Study Start: March 30, 2022
• Primary Completion: March 30, 2024
• Study Completion: August 30, 2024
• Last Updated: December 5, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)