Clinical trial · Interventional
A Study of KC1036 Versus Investigator's Choice of Chemotherapy in Patients With Advanced Esophageal Cancer
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
NCT06194734CI-TRIAL-00074780recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| KC1036 | Drug | — | UNRESOLVED |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- KC1036
- description
- KC1036 will be administrated.
- interventionNames
- Drug: KC1036
- type
- ACTIVE_COMPARATOR
- label
- Investigator's choice of chemotherapy
- description
- Irinotecan, Docetaxel or S-1 will be administrated.
- interventionNames
- Drug: Irinotecan
- Drug: Docetaxel
- Drug: S-1
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- Baseline to study completion (approximately 24 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.