Esophageal Squamous Cell CarcinomaPhase 2NCT03927495
KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
A Phase 2 study testing KN046 and palliative radiotherapy in people with Esophageal Squamous Cell Carcinoma, run by Shanghai Chest Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- KN046 and palliative radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2019to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Suzhou University
Suzhou
Songbing Qin, 8651267780081 ext. 8651267780081, sdfyec@163.com
About this study
Official title: Phase II Study of KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma to Evaluate Safety, Efficacy and Tolerance
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
- Being tested
- KN046, palliative radiotherapy
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN046Drug
Also called Cisplatin+paclitaxel
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 radiotherapyRadiation
3D conformal radiation therapy will be administered for esophageal lesion or nearby lymph node. Stereotactic body radiation will be administered for metastatic lesion.
KN046Drug
Also called Cisplatin+paclitaxel
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.
| Study group | Role | What they receive |
|---|---|---|
| Concurrent chemoradiotherapy and KN046 | Experimental | Participants in the Arm I will receive chemoradiotherapy and concurrent KN046. Radiotherapy will be completed within the four-cycle of chemotherapy. Receives: Drug: KN046; Radiation: palliative radiotherapy |
| chemoradiotherapy and sequential KN046 | Experimental | Participants in the Arm II will receive chemoradiotherapy and sequential KN046. Radiotherapy will be completed within the four-cycle of chemotherapy. Receives: Radiation: palliative radiotherapy; Drug: KN046 |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose-limiting toxicity KN046
Measured: 28 days after first dose
6-month progression free survival rate assessed by investigator based on RECIST 1.1
Measured: 6 months after first dose
Objective response rate assessed by investigator based on RECIST 1.1
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start22 May 2019
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Suzhou Medical College
- Responsible party
- Principal investigator, Xiaolong Fu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927495
- Sponsor's protocol ID
- KN046-IST-01
- Status last verified
- May 2019
- First submitted
- 23 Apr 2019
- Last updated
- 29 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma to Evaluate Safety, Efficacy and Tolerance
- ClinicalTrials.gov ID
- NCT03927495
- Acronym / sponsor ID
- KN046-IST-01
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Suzhou Medical College
- Study start
- 22 May 2019 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 25 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concurrent chemoradiotherapy and KN046 | Experimental | Drug: KN046, Radiation: palliative radiotherapyParticipants in the Arm I will receive chemoradiotherapy and concurrent KN046. Radiotherapy will be completed within the four-cycle of chemotherapy. |
| chemoradiotherapy and sequential KN046 | Experimental | Radiation: palliative radiotherapy, Drug: KN046Participants in the Arm II will receive chemoradiotherapy and sequential KN046. Radiotherapy will be completed within the four-cycle of chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KN046Also: Cisplatin+paclitaxelCisplatin+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. | Drug | Concurrent chemoradiotherapy and KN046 |
| palliative radiotherapy3D conformal radiation therapy will be administered for esophageal lesion or nearby lymph node. Stereotactic body radiation will be administered for metastatic lesion. | Radiation | Concurrent chemoradiotherapy and KN046, chemoradiotherapy and sequential KN046 |
| KN046Also: Cisplatin+paclitaxelCisplatin+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. | Drug | chemoradiotherapy and sequential KN046 |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KN046 and palliative radiotherapy in people with Esophageal Squamous Cell Carcinoma, run by Shanghai Chest Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Songbing Qin, MD (8651267780081 ext. 8651267780081, sdfyec@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dose-limiting toxicity KN046 (time frame: 28 days after first dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019.