NCT07481058 KC1036 in Combination With PD-1 Antibody and Platinum-based Chemotherapy for First-line Advanced Esophageal Cancer
| NCT ID | NCT07481058 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Beijing Konruns Pharmaceutical Co., Ltd. |
| Condition | Esophageal Squamous Cell Carcinoma (ESCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-12-12 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-12-12 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of KC1036 in combination with PD-1 antibody and platinum-based chemotherapy as a first-line treatment for patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).
Eligibility Criteria
Inclusion Criteria: * Males or females aged 18 to 75 years; * Histologically or cytologically confirmed esophageal or esophageal-gastric junction squamous cell carcinoma; * Patients who have not received prior systemic anti-tumor therapy for the current recurrent or metastatic disease; * 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 kg/m2; * Adequate bone marrow, renal, and hepatic function; * Female patients of childbearing potential with a negative blood pregnancy test completed within 7 days before the first dose; * Patients should participate in the study voluntarily and sign informed consent. Exclusion Criteria: * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastasis; * Other malignancies within the past 5 years; * Known hypersensitivity to any monoclonal antibodies or chemotherapy components; * Gastrointestinal abnormalities; * High risk of bleeding or fistula due to tumor invasion of adjacent organs, or existing esophageal/tracheal fistula; * Cardiovascular and cerebrovascular diseases; * Prior therapy with anti-angiogenic drugs or immunotherapy; Systemic therapy, investigational drugs, or live vaccines within 4 weeks prior to the first dose; Palliative radiotherapy within 2 weeks or major surgery within 28 days prior to enrollment; * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; * Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE 5.0 Grade 0 or 1; * Active autoimmune disease or a history of autoimmune disease requiring systemic treatment; * Active infections, including severe infection (CTCAE \> Grade 2) within 4 weeks, active tuberculosis, or positive status for HIV, HBV, or HCV; * 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 conditions assessed by the investigator that would increase safety risks or interfere with the study results.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07481058 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Esophageal Squamous Cell Carcinoma (ESCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07481058 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07481058 currently recruiting?
Yes, NCT07481058 is actively recruiting participants. Contact the research team at huangjingwg@163.com for enrollment information.
Where is the NCT07481058 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07481058 clinical trial?
NCT07481058 is sponsored by Beijing Konruns Pharmaceutical Co., Ltd.. The trial plans to enroll 60 participants.