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

NCT05625737 | Unknown Phase 2

• 1 other identifier: HMPL-013-CC-GC003
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stomach Neoplasms

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

• Progression-Free Survival (PFS)

  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

• Overall Survival (OS)

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

• Disease Control Rate (DCR)

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

• Duration of Response (DoR)

  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

• Adverse Event (AEs)

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

Other Outcomes (1)

• Exploratory endpoint

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

Study Arms (1)

Fruquintinib plus Sintilimab

EXPERIMENTAL

Fruquintinib combined with sintilimab. Fruquintinib: 4 mg/d, qd, po, d1-14, q3w; Sintilimab: 200 mg/d, ivgtt, d1, q3w.

Drug: Fruquintinib; Drug: Sintilimab

Interventions

Fruquintinib DRUG

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

Fruquintinib plus Sintilimab

Sintilimab DRUG

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

Fruquintinib plus Sintilimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Wuhan Union Hospital, China

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

HMPL-013; sintilimab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Hongli Liu, PhD

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

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: Director, Head of GI Department , Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 23, 2022
• Study Start: September 8, 2022
• Primary Completion: December 1, 2024
• Study Completion: September 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)