Clinical Study of Fruquintinib Combined With Sintilimab and XELOX Regimen in the Treatment of Advanced Cancer

NCT06094868 | Not Yet Recruiting Phase 2

• 1 other identifier: HMPL-013-E1-GC002
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

To explore the efficacy and safety of Fruquintinib combined with Sintilimab and XELOX in the first-line treatment of unresectable advanced metastatic gastric or gastroesophageal junction adenocarcinoma.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  The time from enrollment to disease progression or death Outcome 1 Title: Progression-free survival (PFS) Description: The time from enrollment to disease progression or death

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary Outcomes (4)

• Objective response rate (ORR)

  During treatment

• Disease control rate (DCR)

  During treatment

• Overall survival (OS)

  Through study completion, an average of 1 year

• Security

  Through study completion, an average of 1 year

Study Arms (1)

Fruquintinib in combination with Sintilimab and XELOX

EXPERIMENTAL

Fruquintinib: 4mg, QD, PO, D1-D14, Q3W; Sintilimab: weight \< 60kg, 3mg/kg; weight≥60kg, 200 mg; I.V.， D1，Q3W； XELOX regimen: oxaliplatin: 130 mg/m2, ivgtt, D1, Q3W; Capecitabine: 1000 mg/m2, bid, D1-D14, Q3W; After 6 cycles of treatment, chemotherapy was given and maintenance treatment was given with fuquitinib combined with sindillizumab. The above medication regimen can be adjusted according to the adverse reaction tolerance of the subjects. \* Maintenance of treatment until disease progression, or intolerable toxic reactions, or other conditions determined by the investigator

Drug: Fruquintinib

Interventions

Fruquintinib DRUG

Fruquintinib: 4mg, QD, PO, D1-D14, Q3W; Sintilimab: weight \< 60kg, 3mg/kg; weight≥60kg, 200 mg; I.V.， D1，Q3W；. XELOX regimen: Oxaliplatin: 130 mg/m2, ivgtt, D1, Q3W; Capecitabine: 1000 mg/m2, bid, D1-D14, Q3W; After 6 cycles of treatment, chemotherapy was given and maintenance treatment was given with Fruquintinib combined with Sintilimab. The above medication regimen can be adjusted according to the adverse reaction tolerance of the subjects. \* Maintenance of treatment until disease progression, or intolerable toxic reactions, or other conditions determined by the investigator

Also known as: Sintilimab, Oxaliplatin, Capecitabine

Fruquintinib in combination with Sintilimab and XELOX

Eligibility Criteria

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

You may qualify if:

• Have fully understood the study and voluntarily signed the informed consent;
• Histologically and/or cytologically confirmed unresectable advanced gastric or gastroesophageal junction adenocarcinoma;
• Age 18-75 (including 18 and 75 years old);
• ECOG physical condition 0-1 score;
• Locally advanced unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma that has not received systemic therapy before (Note: Time from the end of previous (new) adjuvant chemotherapy/adjuvant radiotherapy to disease recurrence \&gt; 6 months);
• For local lesions (non-target lesions), the time from the end of palliative treatment to random enrollment was \> 2 weeks;
• At least one measurable or evaluable lesion according to RECIST v1.1 criteria;
• Negative Her2;
• Expected survival ≥3 months;
• The functions of vital organs during the first 14 days of enrollment met the following requirements:
• Absolute neutrophil count ≥1.5×109/L;
• Platelet ≥80×109/L;
• Hemoglobin ≥90g/L;
• Total bilirubin \< 1.5 ULN;
• ALT and AST \< 2.5 ULN (\< 5 ULN in patients with liver metastasis);

You may not qualify if:

• Failure to comply with the study protocol or study procedure;
• Previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors or previous treatment with immune checkpoint inhibitors;
• Have had other malignancies within the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
• Known presence of symptomatic central nervous system metastasis and/or cancerous meningitis. Participants with previously treated BMS may participate in the trial if their condition is stable (no evidence of radiographic progression at least 4 weeks prior to initial administration of the trial treatment), repeated radiographic studies confirm no evidence of new BMS or enlargement of the original BMS, and no steroid therapy is required at least 14 days prior to initial administration of the trial treatment. This exception does not include cancerous meningitis, which should be excluded regardless of whether it is clinically stable;
• Had autoimmune disease or history of autoimmune disease within 4 weeks before enrollment;
• Previously received allogeneic bone marrow transplantation or organ transplantation;
• Uncontrolled malignant ascites (defined as ascites that cannot be controlled by diuretics or puncture as determined by the researcher);
• Severe cardiovascular disease, including unstable angina pectoris or myocardial infarction, occurs within 6 months before the start of study treatment;
• Subjects who are allergic to the investigational drug or any of its adjuncts;
• Participated in other domestic unapproved or unmarketed drug clinical trials and accepted the corresponding experimental drug treatment within 4 weeks before enrollment;
• Had a major surgical procedure (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study therapy or expected to require major surgery during study therapy.
• International Standardized Ratio (INR) \&gt; 1.5 or partially activated prothrombin time (APTT) \&gt; 1.5×ULN;
• The investigator identified clinically significant electrolyte abnormalities;
• Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg;
• Poorly controlled diabetes mellitus was present before enrollment (fasting glucose concentration ≥CTCAE level 2 after formal treatment);

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

HMPL-013; sintilimab; Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Wang Hua, Director

  Second Affiliated Hospital of Nanchang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Hua, Director

CONTACT

13667098735; 13667098735@163.com

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

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 23, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 23, 2023

Record last verified: 2023-10