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Advanced Esophageal Squamous Cell CarcinomaPhase 2NCT06512428

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

A Phase 2 study testing simmitinib plus irinotecan liposome, irinotecan liposome and irinotecan in people with Advanced Esophageal Squamous Cell Carcinoma, run by Shanghai Runshi Pharmaceutical Technology Co., Ltd at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
simmitinib plus irinotecan liposome, irinotecan liposome and irinotecan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
1 siteChina
Study dates
15 Mar 2024to 30 Jan 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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

Trial locations and contacts

1 site in 1 country.

Clinical Trials Information Group officer contact

86-0311-69085587

ctr-contact@cspc.cn

China1 site, 1 recruiting

  • Harbin Medical University Cancer Hospital

    Heilongjiang, Harbin, 150076

    Yanqiao Zhang, Ph.D, 0451-86298222, yanqiaozhanggcp@163.com

    Recruiting

Other trials in China

About this study

Official title: An Open-label, Multicenter Phase II Clinical Trial to Explore the Safety and Efficacy of Simmitinib Plus Irinotecan Liposome in Patients With Advanced Esophageal Squamous Cell Carcinoma

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.

Read the detailed description

The experiment was divided into two stages. The first stage is dose escalation stage. Rapid titration and "3+3" dose escalation design were used to observe DLT of simmitinib plus irinotecan liposome, and MTD was determined. The second stage is a randomized controlled study. After RP2D was determined in the first stage, participants were randomly assigned to 3 groups in a 1:1:1 ratio, including simmitinib plus irinotecan liposome, irinotecan liposome, and irinotecan.

Being tested
simmitinib plus irinotecan liposome, irinotecan liposome, irinotecan

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • simmitinib plus irinotecan liposomeDrug

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

  • irinotecan liposomeDrug

    irinotecan liposome 70 mg/m^2 every 2 weeks

  • irinotecanDrug

    irinotecan 180mg/m^2 every 2 weeks

Study groups in NCT06512428
Study groupRoleWhat they receive
simmitinib plus irinotecan liposomeExperimentalNot described
Receives: Drug: simmitinib plus irinotecan liposome
irinotecan liposomeExperimentalNot described
Receives: Drug: irinotecan liposome
irinotecanExperimentalNot described
Receives: Drug: irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Escalation Phase: DLT

    Dose Limited Toxicity

    Measured: 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

    Measured: 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

    Measured: 2 years

Secondary outcomes (7)

  1. DCR

    Disease Control Rate

    Measured: 2 years

  2. PFS

    Progression-free Survival

    Measured: 2 years

  3. OS

    Overall Survival

    Measured: 2 years

  4. DOR

    Duration of Objective Response

    Measured: 2 years

  5. Area under plasma concentration (AUC)

    Area under the plasma concentration versus time curve (AUC) of simmitinib

    Measured: 2 years

  6. Peak Plasma Concentration (Cmax)

    Peak Plasma Concentration (Cmax) of simmitinib

    Measured: 2 years

  7. Time of peak plasma concentration (Tmax)

    Time of peak plasma concentration (Tmax) of simmitinib

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2024
  2. Study start15 Mar 2024
  3. Primary completion30 Jan 2026 (estimated)
  4. Study completion30 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
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.
Masking
None (open label)
Enrolment
138 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06512428
Sponsor's protocol ID
HA1818-004
Status last verified
Jul 2024
First submitted
9 Jul 2024
Last updated
22 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing simmitinib plus irinotecan liposome, irinotecan liposome and irinotecan in people with Advanced Esophageal Squamous Cell Carcinoma, run by Shanghai Runshi Pharmaceutical Technology Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Escalation Phase: DLT (time frame: From Cycle 1 Day 1 to Cycle 1 Day 28 (each cycle is 28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06512428.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.

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