Esophageal Squamous Cell Carcinoma
Conditions
Brief summary
This is an open-label, phase II study of KN046 combined with chemotherapy and palliative radiotherapy in patients with recurrent or metastatic esophageal squamous cell carcinoma to evaluate the safety, efficacy and tolerance.
Interventions
DRUGKN046
Cisplatin+paclitaxel will be administered once every three weeks for four cycles. During the period of radiotherapy, KN046 will be administered once every two weeks until progressive disease, unacceptable toxicity or up to 2 years.
RADIATIONpalliative radiotherapy
3D conformal radiation therapy will be administered for esophageal lesion or nearby lymph node. Stereotactic body radiation will be administered for metastatic lesion.
Sponsors
First Affiliated Hospital of Suzhou Medical College
Shanghai Chest Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Signed inform consent form(ICF) * Age ≥ 18 years and ≤ 75 years, male or female * Histologically or cytologically documented recurrent or metastatic esophageal squamous cell carcinoma, with indications of radiotherapy and without prior systemic treatment * At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors（RECISIT） v 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ function * Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed. * Ability to comply with treatment, procedures and pharmacokinetics (PK) sample collection and the required study follow-up procedures
Exclusion criteria
* Known brain metastasis or another Central Nervous System (CNS) metastasis that is either symptomatic or untreated. * Patients who are participating or have participated in a study of an investigational drug within 4 weeks prior to the first dose of trial treatment. * Patients who have received immune checkpoint proteins/antibody/medicine for treatment. * Patients who have interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management. * Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded * Active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection. * Known HIV infection or known history of acquired immune deficient syndrome (AIDS) * Any unresolved the Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 toxicities from prior anti-cancer therapy except for vitiligo, alopecia * Patients who have serious hypersensitive reaction to monoclonal antibodies and have history of uncontrolled allergic asthma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dose-limiting toxicity KN046 | 28 days after first dose |
| 6-month progression free survival rate assessed by investigator based on RECIST 1.1 | 6 months after first dose |
| Objective response rate assessed by investigator based on RECIST 1.1 | 2 years |
Countries
China
Contacts
Primary ContactSongbing Qin, MD
Outcome results
None listed