A Study of Simmitinib Plus Irinotecan in Advanced Esophageal Squamous Cell Carcinoma

NCT06512428 | Recruiting Phase 2

• 1 other identifier: HA1818-004
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of simmitinib plus irinotecan liposome in the treatment of advanced esophageal squamous cell carcinoma, and to evaluate the PK of the drug and the correlation between biomarkers and clinical efficacy of simmitinib plus irinotecan liposome.

Conditions

Advanced Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

• Dose Escalation Phase: DLT

  Dose Limited Toxicity

  From Cycle 1 Day 1 to Cycle 1 Day 28 (each cycle is 28 days)

• Dose Escalation Phase: AE

  Incidence rate of Adverse Event

  From first dose to 30 days post the last dose

• Randomized controlled study phase: ORR

  Objective Response Rate (ORR) evaluated by investigators based on RECIST 1.1

  2 years

Secondary Outcomes (7)

• DCR

  2 years

• PFS

  2 years

• OS

  2 years

• DOR

  2 years

• Area under plasma concentration (AUC)

  2 years

Study Arms (3)

simmitinib plus irinotecan liposome

EXPERIMENTAL

Drug: simmitinib plus irinotecan liposome

irinotecan liposome

EXPERIMENTAL

Drug: irinotecan liposome

irinotecan

EXPERIMENTAL

Drug: irinotecan

Interventions

simmitinib plus irinotecan liposome DRUG

simmitinib plus irinotecan liposome 70 mg/m\^2 every 2 weeks

simmitinib plus irinotecan liposome

irinotecan liposome DRUG

irinotecan liposome 70 mg/m\^2 every 2 weeks

irinotecan liposome

irinotecan DRUG

irinotecan 180mg/m\^2 every 2 weeks

irinotecan

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have fully understood and voluntarily sign the ICF for this study;
• Age of 18-70 years (inclusive), male or female;
• Esophageal squamous cell carcinoma confirmed histologically or cytologically
• Second-line patients with disease progression after only first-line standard therapy（Standard treatment: chemotherapy with platinum plus fluorouracil or taxane combined with immunosuppressive regimen .Progression during adjuvant/neoadjuvant therapy or within 6 months of the last dose is considered a first-line standard treatment failure）
• At least one measurable lesion according to RECIST 1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1;
• Expected survival is more than 3 months
• Adequate organ function, defined as:
• Absolute Neutrophil count (ANC) ≥ 1.5 × 10\^9/L; Platelet count (PLT) ≥ 75× 10\^9/L; Hemoglobin (Hb) ≥ 90 g/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN) (≤ 5.0 × ULN for patients with liver metastases); Serum total bilirubin (TBIL) ≤ 1.5 × ULN; Serum creatinine ≤ 1.5 × ULN and Creatinine clearance (CCr)≥60mL/min; Prothrombin time (PT)、activated partial thromboplastin time (APTT)、international normalized ratio(INR)≤1.5 × ULN;
• Male and female patients of childbearing age must agree to take effective contraceptive measures during treatment and within 6 months after the last dose of treatment.

You may not qualify if:

• Patients who have previously received any anti-tumor therapy within 4 weeks prior to the first dose;
• Patients who have previously received any live attenuated vaccine within 4 weeks before the first use of the study treatment or are expected to received any live attenuated vaccine during the study;
• Prior systemic treatment with anti-VEGF drugs, irinotecan, or any other topoisomerase I inhibitor
• LVEF \<50%；
• BMI≤18.5 kg/m\^2
• Symptomatic central nervous system (CNS) metastases or meningeal metastases;
• Patients with other types of malignant tumors within 5 years prior to the screening, except for radically resected, non-recurrent skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ, or other carcinoma in situ;
• Patients with bleeding tendency; active bleeding or a history of heavy bleeding within the past 6 months;
• Urine protein ≥ ++ and 24 h urine protein \> 1.0g at screening period;
• Presence of any severe and/or uncontrolled disease before starting treatment;
• Severe lung disease within 6 months before first dosing ；
• Any active infection requiring antibiotics or hormones systemic treatment by intravenous infusion within 14 days prior to the first dose;
• Inability to swallow drugs orally, or presence of clinically significant gastrointestinal disorders

Sponsors & Collaborators

• Shanghai Runshi Pharmaceutical Technology Co., Ltd: lead

Study Sites (1)

Harbin Medical University Cancer Hospital

Heilongjiang, Harbin, 150076, China

RECRUITING

MeSH Terms

Interventions

irinotecan sucrosofate; Irinotecan

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Yanqiao Zhang, Ph.D

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose Escalation Phase: Dose 1: simmitinib 4mg QD plus irinotecan liposome 70 mg/m\^2 every 2 weeks; Dose 2: simmitinib 6mg 3 weeks on 1 week off plus irinotecan liposome 70 mg/m\^2 every 2 weeks; Dose 3: simmitinib 6mg QD plus irinotecan liposome 70 mg/m\^2 every 2 weeks; Randomized controlled study Phase: Randomly assigned to the following 3 groups at 1:1:1 ratio, including simmitinib plus irinotecan liposome, irinotecan liposome, and irinotecan.

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 22, 2024
• Study Start: March 15, 2024
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)