KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
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| ClinicalTrials.gov Identifier: NCT03927495 |
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Recruitment Status : Unknown
Verified May 2019 by Xiaolong Fu, Shanghai Chest Hospital.
Recruitment status was: Recruiting
First Posted : April 25, 2019
Last Update Posted : May 29, 2019
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Sponsor:
Shanghai Chest Hospital
Collaborator:
First Affiliated Hospital of Suzhou Medical College
Information provided by (Responsible Party):
Xiaolong Fu, Shanghai Chest Hospital
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Esophageal Squamous Cell Carcinoma | Drug: KN046 Radiation: palliative radiotherapy | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Study of KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma to Evaluate Safety, Efficacy and Tolerance |
| Actual Study Start Date : | May 22, 2019 |
| Estimated Primary Completion Date : | June 30, 2021 |
| Estimated Study Completion Date : | December 31, 2021 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Drug: 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.
Other Name: Cisplatin+paclitaxel Radiation: 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. |
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Experimental: 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.
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Radiation: 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. Drug: 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.
Other Name: Cisplatin+paclitaxel |
Primary Outcome Measures :
- dose-limiting toxicity KN046 [ Time Frame: 28 days after first dose ]
- 6-month progression free survival rate assessed by investigator based on RECIST 1.1 [ Time Frame: 6 months after first dose ]
- Objective response rate assessed by investigator based on RECIST 1.1 [ Time Frame: 2 years ]
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927495
Contacts
| Contact: Songbing Qin, MD | 8651267780081 ext 8651267780081 | sdfyec@163.com |
Locations
| China | |
| The First Affiliated Hospital of Suzhou University | Recruiting |
| Suzhou, China | |
| Contact: Songbing Qin 8651267780081 ext 8651267780081 sdfyec@163.com | |
Sponsors and Collaborators
Shanghai Chest Hospital
First Affiliated Hospital of Suzhou Medical College
| Responsible Party: | Xiaolong Fu, Director, Department of Radiation Oncology, Shanghai Chest Hospital |
| ClinicalTrials.gov Identifier: | NCT03927495 |
| Other Study ID Numbers: |
KN046-IST-01 |
| First Posted: | April 25, 2019 Key Record Dates |
| Last Update Posted: | May 29, 2019 |
| Last Verified: | May 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Squamous Cell Esophageal Squamous Cell Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms |
Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Paclitaxel Albumin-Bound Paclitaxel Cisplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |