Esophageal Squamous Cell CarcinomaPhase 3NCT06194734
A Study of KC1036 Versus Investigator's Choice of Chemotherapy in Patients With Advanced Esophageal Cancer
A Phase 3 study testing KC1036, Irinotecan and Docetaxel in people with Esophageal Squamous Cell Carcinoma, run by Beijing Konruns Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of KC1036 versus investigator's choice of chemotherapy in patients with advanced recurrent or metastatic esophageal squamous cell carcinoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- KC1036, Irinotecan and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2024to 30 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged 18 to 75 years;
- Histologically or cytologically confirmed esophageal or esophageal-gastric junction squamous cell carcinoma;
- Patient with advanced recurrent or metastatic esophageal squamous cell carcinoma previously treated with a PD-1 or PD-L1 inhibitor and at least second-line systemic therapy;
- At least one measurable tumor lesion according to RECIST 1.1;
- Eastern Cooperative Oncology Group performance status score of 0 or 1;
- Life expectancy > 12 weeks;
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- BMI≥16.0 and weight≥40 kg ;
- Adequate bone marrow, renal, and hepatic function;
- Female patients of childbearing potential with a negative blood pregnancy test completed within 7 days before randomization；
- Patients should participate in the study voluntarily and sign informed consent.
Who cannot join
- Any patient who is known to have untreated central nervous system (CNS) metastasis;
- Other kinds of malignancies within 5 years;
- Gastrointestinal abnormalities;
- Cardiovascular and cerebrovascular diseases;
- Prior therapies with vascular targeting inhibitor；
- Previously treated with Irinotecan, Docetaxel and Tegafur Gimeracil Oteracil Potassium；
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- Involved in other clinical trials within 4 weeks before enrollment；Prior anti-tumor therapies with radiotherapy, immunotherapy, operation within 4 weeks before enrollment;Prior anti-tumor therapies with small molecule targeting drugs within 2weeks or 5 half-lives (whichever is longer) before enrollment; Prior anti-tumor therapies with chemotherapy within 3 weeks or 5 half-lives (whichever is longer) before enrollment;
- Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE 5.0 Grade 0 or 1;
- Uncontrolled massive ascites, pleural or pericardial effusion;
- Severe infection within 4 weeks prior to randomization (CTCAE > Grade 2);
- Known history of human immunodeficiency virus (HIV) infection or current active hepatitis B or C infection;
- Pregnant or lactating women;
- Female subjects of child-bearing potential and male subjects of reproductive capacity who do not agree to use contraceptive measures during the study and for 6 months after the end of the study.
- Other patients are not eligible for enrollment assessed by investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Jing Huang, Ph.D, 010-87788293, huangjingwg@163.com
About this study
Official title: A Randomized, Controlled, Open-label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of KC1036 Versus Investigator's Choice of Chemotherapy as Third-line Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma
The purpose of this study is to evaluate the efficacy and safety of KC1036 versus investigator's choice of chemotherapy in patients with advanced recurrent or metastatic esophageal squamous cell carcinoma
Read the detailed description
This is a randomized, controlled, open-label, multicenter phase III trial. Patients with advanced recurrent or metastatic esophageal squamous cell carcinoma that has received PD-1 or PD-L1 inhibitors and at least second-line systemic therapy will be randomized at a 1: 1 ratio to receive KC1036 or the investigator's choice of chemotherapy (Irinotecan/Docetaxel/S-1) until confirmed disease progression assessed by the RECIST V1.1 standard, death, intolerable toxicity, initiation of a new anti-tumor therapy, other reasons leading to treatment discontinuation as specified by protocol.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- KC1036, Irinotecan, Docetaxel, S-1
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KC1036Drug
KC1036 60mg QD orally, before a meal, continuous administration, 21 days as a cycle
IrinotecanDrug
Irinotecan intravenously administered at 130-150 mg/m2 once every 2 weeks
DocetaxelDrug
Docetaxel intravenously administered at 60-75 mg/m2 once every 3 weeks；
S-1Drug
Also called Tegafur-gimeracil-oteracil potassium
S-1 orally administered 40-60mg Bid on Day 1 to Day 14 of every 3 weeks, 21 days as a cycle
| Study group | Role | What they receive |
|---|---|---|
| KC1036 | Experimental | KC1036 will be administrated. Receives: Drug: KC1036 |
| Investigator's choice of chemotherapy | Active comparator | Irinotecan, Docetaxel or S-1 will be administrated. Receives: Drug: Irinotecan; Drug: Docetaxel; Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS is defined as the time from the start of randomization to death of any cause.
Measured: Baseline to study completion (approximately 24 months)
Secondary outcomes (6)
Objective Response Rate (ORR)
ORR is defined as the proportions of patients with a complete response (CR) or partial response (PR) according to RECIST 1.1.
Measured: Baseline to study completion (approximately 24 months)
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with a best overall complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1.
Measured: Baseline to study completion (approximately 24 months)
Duration of Response (DOR)
DOR is defined as the time from first documented objective response (complete response (CR)or partial response (PR)) to the date of first documented disease progression (PD) or death.
Measured: Baseline to study completion (approximately 24 months)
Progression-free survival (PFS)
PFS is defined as the time from the start of randomization to the date of the first documented progressive disease (PD) according to RECIST 1.1 or death.
Measured: Baseline to study completion (approximately 24 months)
Incidence of Adverse events (AEs)
Assessed by treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the treatment assessed by NCI CTCAE 5.0.
Measured: Baseline to 30 days after the last dose of study treatment
Quality of Life (QOL) scores
Quality of Life is a concept of comprehensive evaluation of the advantages and disadvantages of life. It mainly refers to the assessment of individual physiological, psychological and social functions, which is an important indicator of the effectiveness of medical and health care services.
Measured: Baseline to study completion (approximately 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start5 Feb 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Konruns Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing Huang, Ph.D, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194734
- Sponsor's protocol ID
- KC1036-III-01
- Status last verified
- Mar 2024
- First submitted
- 22 Dec 2023
- Last updated
- 7 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of KC1036 Versus Investigator's Choice of Chemotherapy as Third-line Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06194734
- Acronym / sponsor ID
- KC1036-III-01
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Beijing Konruns Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of KC1036 versus investigator's choice of chemotherapy in patients with advanced recurrent or metastatic esophageal squamous cell carcinoma
Detailed description
This is a randomized, controlled, open-label, multicenter phase III trial. Patients with advanced recurrent or metastatic esophageal squamous cell carcinoma that has received PD-1 or PD-L1 inhibitors and at least second-line systemic therapy will be randomized at a 1: 1 ratio to receive KC1036 or the investigator's choice of chemotherapy (Irinotecan/Docetaxel/S-1) until confirmed disease progression assessed by the RECIST V1.1 standard, death, intolerable toxicity, initiation of a new anti-tumor therapy, other reasons leading to treatment discontinuation as specified by protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KC1036 | Experimental | Drug: KC1036KC1036 will be administrated. |
| Investigator's choice of chemotherapy | Active comparator | Drug: Irinotecan, Drug: Docetaxel, Drug: S-1Irinotecan, Docetaxel or S-1 will be administrated. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males or females aged 18 to 75 years;
- Histologically or cytologically confirmed esophageal or esophageal-gastric junction squamous cell carcinoma;
- Patient with advanced recurrent or metastatic esophageal squamous cell carcinoma previously treated with a PD-1 or PD-L1 inhibitor and at least second-line systemic therapy;
- At least one measurable tumor lesion according to RECIST 1.1;
- Eastern Cooperative Oncology Group performance status score of 0 or 1;
Key exclusion criteria (14 listed)
- Any patient who is known to have untreated central nervous system (CNS) metastasis;
- Other kinds of malignancies within 5 years;
- Gastrointestinal abnormalities;
- Cardiovascular and cerebrovascular diseases;
- Prior therapies with vascular targeting inhibitor；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KC1036KC1036 60mg QD orally, before a meal, continuous administration, 21 days as a cycle | Drug | KC1036 |
| IrinotecanIrinotecan intravenously administered at 130-150 mg/m2 once every 2 weeks | Drug | Investigator's choice of chemotherapy |
| DocetaxelDocetaxel intravenously administered at 60-75 mg/m2 once every 3 weeks； | Drug | Investigator's choice of chemotherapy |
| S-1Also: Tegafur-gimeracil-oteracil potassiumS-1 orally administered 40-60mg Bid on Day 1 to Day 14 of every 3 weeks, 21 days as a cycle | Drug | Investigator's choice of chemotherapy |
Primary outcome
Overall survival (OS)
Time frame: Baseline to study completion (approximately 24 months)
OS is defined as the time from the start of randomization to death of any cause.
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: Baseline to study completion (approximately 24 months)
Disease Control Rate (DCR)
Time frame: Baseline to study completion (approximately 24 months)
Duration of Response (DOR)
Time frame: Baseline to study completion (approximately 24 months)
Progression-free survival (PFS)
Time frame: Baseline to study completion (approximately 24 months)
Incidence of Adverse events (AEs)
Time frame: Baseline to 30 days after the last dose of study treatment
Quality of Life (QOL) scores
Time frame: Baseline to study completion (approximately 24 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing Huang, Ph.D principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KC1036, Irinotecan and Docetaxel in people with Esophageal Squamous Cell Carcinoma, run by Beijing Konruns Pharmaceutical 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 14 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: looking for participants now, as of the sponsor's last update on 7 Mar 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Huang, Ph.D (010-87788293, huangjingwg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: Baseline to study completion (approximately 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2024.