KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

NCT ID: NCT03927495

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-22
• Study Completion Date: 2021-12-31

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.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Concurrent chemoradiotherapy and KN046

Participants in the Arm I will receive chemoradiotherapy and concurrent KN046. Radiotherapy will be completed within the four-cycle of chemotherapy.

Group Type: EXPERIMENTAL

KN046

Intervention Type: DRUG

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.

palliative radiotherapy

Intervention Type: RADIATION

3D conformal radiation therapy will be administered for esophageal lesion or nearby lymph node. Stereotactic body radiation will be administered for metastatic lesion.

chemoradiotherapy and sequential KN046

Participants in the Arm II will receive chemoradiotherapy and sequential KN046. Radiotherapy will be completed within the four-cycle of chemotherapy.

Group Type: EXPERIMENTAL

palliative radiotherapy

Intervention Type: RADIATION

3D conformal radiation therapy will be administered for esophageal lesion or nearby lymph node. Stereotactic body radiation will be administered for metastatic lesion.

KN046

Intervention Type: DRUG

Cisplatin+paclitaxel will be administered once every three weeks for four cycles. After completion of radiotherapy, KN046 will be administered once every two weeks until progressive disease, unacceptable toxicity or up to 2 years.

Interventions

KN046

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.

Intervention Type: DRUG

palliative radiotherapy

3D conformal radiation therapy will be administered for esophageal lesion or nearby lymph node. Stereotactic body radiation will be administered for metastatic lesion.

Intervention Type: RADIATION

KN046

Cisplatin+paclitaxel will be administered once every three weeks for four cycles. After completion of radiotherapy, KN046 will be administered once every two weeks until progressive disease, unacceptable toxicity or up to 2 years.

Intervention Type: DRUG

Other Intervention Names

Cisplatin+paclitaxel; Cisplatin+paclitaxel

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Suzhou Medical College

OTHER

Sponsor Role: collaborator

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaolong Fu

Director, Department of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital of Suzhou University

Suzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Songbing Qin, MD

Role: CONTACT

sdfyec@163.com

8651267780081 ext. 8651267780081

Facility Contacts

Songbing Qin

Role: primary

sdfyec@163.com

8651267780081 ext. 8651267780081

Other Identifiers

KN046-IST-01

Identifier Type: -

Identifier Source: org_study_id