Clinical trial
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
Name
KC1036-III-01
Description
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
Trial arms
Trial start
2024-02-05
Estimated PCD
2026-12-30
Trial end
2027-12-30
Status
Recruiting
Phase
Early phase I
Treatment
KC1036
KC1036 60mg QD orally, before a meal, continuous administration, 21 days as a cycle
Arms:
KC1036
Irinotecan
Irinotecan intravenously administered at 130-150 mg/m2 once every 2 weeks
Arms:
Investigator's choice of chemotherapy
Docetaxel
Docetaxel intravenously administered at 60-75 mg/m2 once every 3 weeks；
Arms:
Investigator's choice of chemotherapy
S-1
S-1 orally administered 40-60mg Bid on Day 1 to Day 14 of every 3 weeks, 21 days as a cycle
Arms:
Investigator's choice of chemotherapy
Other names:
Tegafur-gimeracil-oteracil potassium
Size
490
Primary endpoint
Overall survival (OS)
Baseline to study completion (approximately 24 months)
Eligibility criteria
Inclusion Criteria:
* 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;
* 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.
Exclusion Criteria:
* 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；
* 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 490, 'type': 'ESTIMATED'}}
Updated at
2024-03-07
1 organization
Organization
Beijing Konruns Pharmaceutical