Health TrialsbyHealthPanel

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

ConditionAdvanced Esophageal Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai Runshi Pharmaceutical Technology Co., Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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）

Disqualifiers

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%；

Trial design

Design model

Sequential

Treatments tested in this trial

  • simmitinib plus irinotecan liposome

    Drug

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

  • irinotecan liposome

    Drug

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

  • irinotecan

    Drug

    irinotecan 180mg/m\^2 every 2 weeks

Treatment groups

138 Participants
are divided into 3 treatment groups
Group A: simmitinib plus irinotecan liposomeExperimental treatment 1 intervention
Group B: irinotecan liposomeExperimental treatment 1 intervention
Group C: irinotecanExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose Escalation Phase: DLT

Dose Limited Toxicity

Time frame
From Cycle 1 Day 1 to Cycle 1 Day 28 (each cycle is 28 days)
2

Dose Escalation Phase: AE

Incidence rate of Adverse Event

Time frame
From first dose to 30 days post the last dose
3

Randomized controlled study phase: ORR

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

Time frame
2 years

Secondary outcomes

1

DCR

Disease Control Rate

Time frame
2 years
2

PFS

Progression-free Survival

Time frame
2 years
3

OS

Overall Survival

Time frame
2 years
4

DOR

Duration of Objective Response

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Runshi Pharmaceutical Technology Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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