Actively Recruiting
A Phase II Study of KC1036 Combined with PD-1 Antibody and Platinum-based Chemotherapy as First-line Treatment for Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Led by Beijing Konruns Pharmaceutical Co., Ltd. · Updated on 2026-03-20
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of KC1036 combined with a PD-1 antibody called Toripalimab and platinum-based chemotherapy as a first treatment for people with advanced esophageal squamous cell carcinoma that cannot be removed by surgery, or has returned or spread. This Phase II study aims to find the best dose and assess how well this combination works in treating this type of esophageal cancer. The study includes two main parts: a Phase IIa dose-escalation and expansion phase where participants receive one of three doses of KC1036 (20 mg, 30 mg, or 40 mg) daily along with fixed doses of Toripalimab, Paclitaxel, and Cisplatin given intravenously every three weeks. After this, a Phase IIb randomized phase will assign participants to one of the selected doses of KC1036 combined with the same drugs to further evaluate safety and effectiveness. Treatment continues until disease progression, intolerable side effects, or other reasons require stopping. Participants will undergo regular assessments including tumor scans measured by RECIST 1.1 criteria, lab tests, and monitoring of side effects throughout the study, which lasts about 24 months. The main outcome measure is the objective response rate, with additional evaluations including progression-free survival, disease control rate, duration of response, and adverse events. Safety is monitored up to 30 days after the last treatment dose. Participants must meet specific health criteria and agree to follow study procedures during this period.
CONDITIONS
Brief Title
KC1036 in Combination With PD-1 Antibody and Platinum-based Chemotherapy for First-line Advanced Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 to 75 years
- Histologically or cytologically confirmed esophageal or esophageal-gastric junction squamous cell carcinoma
- No prior systemic anti-tumor therapy for 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 greater than 12 weeks
- Body mass index of at least 16.0 kg/m2
- Adequate bone marrow, kidney, and liver function
- Female patients of childbearing potential must have a negative pregnancy test within 7 days before the first dose
- Voluntary participation with signed informed consent
You will not qualify if you...
- Symptomatic, untreated, or actively progressing central nervous system metastasis
- Other cancers within the past 5 years
- Known allergy to monoclonal antibodies or chemotherapy components
- Gastrointestinal abnormalities
- High risk of bleeding or fistula due to tumor invasion or existing esophageal/tracheal fistula
- Cardiovascular or cerebrovascular diseases
- Prior anti-angiogenic, immunotherapy, systemic therapy, investigational drugs, or live vaccines within specified time frames before dosing
- Uncontrolled pleural, pericardial effusion, or ascites requiring repeated drainage
- Unresolved toxicities from prior anti-tumor therapy above grade 1
- Active autoimmune disease requiring systemic treatment
- Active infections including severe infection, tuberculosis, HIV, HBV, or HCV
- Pregnant or breastfeeding women
- Subjects not agreeing to use contraception during the study and for 6 months after
- Other conditions increasing safety risks or interfering with study results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until confirmed disease progression, intolerable toxicity, initiation of a new anti-tumor therapy, or other reasons for discontinuation as specified by the protocol, up to approximately 24 months
Participants receive daily oral KC1036 combined with intravenous toripalimab, paclitaxel, and cisplatin every 3 weeks as first-line treatment for advanced esophageal squamous cell carcinoma.
Visits every 3 weeks at the start of each treatment cycle; paclitaxel and cisplatin are administered for up to 6 cycles
Duration - 30 days after last dose
Participants are monitored for safety and adverse events for 30 days after the last dose of study treatment.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021
Actively Recruiting
Research Team
J
Jing Huang, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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