Thoracic MalignanciesPhase 2CARTAINCT03732430
CT-Guided Adaptive Radiation Therapy Combine With Anti-PD-1 Antibody Adjuvant Immunotherapy for Thoracic Cancer Patients
A Phase 2 study testing IBI308 in people with Thoracic Malignancies, run by Taizhou Hospital at 1 site in China.
Trial summary
This phase II study is to evaluate the safety and efficacy of CT-based adaptive radiation therapy followed by adjuvant anti-PD-1 antibody immunotherapy in treating patients with different types and stages of thoracic malignancies. (CARTAI) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thoracic Malignancies
- What is being tested?
- IBI308
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2018to 31 May 2022
- 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
- Age >= 18 years and <= 75 years
- Histologically or cytologically confirmed advanced/metastatic thoracic malignancies
- Patients must receive adaptive radiation therapy within 45 days before the first dose of trial treatment
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Life expectancy >= 8 weeks
- Adequate hematologic and end organ function
Who cannot join
- Prior exposure to any immune checkpoint inhibitors including but not limited to anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibodies.
- Prior exposure to any other thoracic radiation therapy before this time radiation therapy.
- Prior exposure to steroid therapy or any other form of immunosuppressive therapy within 14 days before the first dose of trial treatment
- No active second cancers
- Active or prior autoimmune disease or immunodeficiency.
- Active infections including but not limited to hepatitis B, C ,and HIV.
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- Significant cardiovascular disease
- Active or untreated central nervous system (CNS) metastases
- Any unresolved toxicity CTCAE >= Grade 3 from the prior radiation therapy.
- Known hypersensitivity to humanized antibodies or fusion proteins or any of study drug excipients.
- Known psychiatric or physical impairments that would interfere with cooperation with the protocol of this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317000
Haihua Yang, MD, +86 13819639006, yhh93181@hotmail.com
Yinnan Meng, MD, +86 13486208109, mengyn6484@enzemed.com
About this study
Official title: A Safety and Efficacy Study of CT-Guided Adaptive Radiation Therapy With Anti-PD-1 Antibody Adjuvant Immunotherapy in Patients With Thoracic Cancer (CARTAI)
This phase II study is to evaluate the safety and efficacy of CT-based adaptive radiation therapy followed by adjuvant anti-PD-1 antibody immunotherapy in treating patients with different types and stages of thoracic malignancies. (CARTAI)
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the safety and toxicity of anti-programmed cell death 1 (PD-1) inhibition consolidation therapy after radiation therapy for multiple thoracic malignancies.
SECONDARY OBJECTIVES:
- To assess the efficacy of adjuvant anti-PD-1 antibody immunotherapy after radiotherapy.
II. To understand the dynamics and interactions of IDO with others immune pathway biomarkers.
III. To evaluate whether IDO immune status could predict the treatment outcomes of radiation and immune combined therapy.
- Conditions
- Thoracic Malignancies
- Being tested
- IBI308
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI308Drug
A humanized anti-PD-1 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Anti-PD-1 antibody | Experimental | IBI308 200mg intravenous drip every three weeks following adaptive radiation therapy. Receives: Drug: IBI308 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs and SAEs at 6 months
Number of participants with adverse events and serious adverse events at 6 months will be measured. [CTCAE v4.03]
Measured: 6 months
Secondary outcomes (5)
ORR
Objective response rate is the percentage of patients with at least once occurrence of PR or CR [RECIST v1.1]
Measured: Estimated to be up to 3 years
DoR
Duration of response is the time interval from first occurrence of PR or CR until PD or death [RECIST v1.1]
Measured: Estimated to be up to 3 years
AEs
Number of patients with acute and chronic adverse events will be measured [CTCAE v4.03]
Measured: Estimated to be up to 3 years
PFS
Progression-Free-Survival is the time interval from the start of treatment until disease progression or death by any cause [RECIST v1.1]
Measured: Estimated to be up to 3 years
OS
Overall Survival is the time interval from the start of treatment to death from any cause.
Measured: Estimated to be up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start14 Nov 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic MalignanciesStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taizhou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haihua Yang, Taizhou Hospital
- Investigators
- Fengming (Spring) Kong, MD, Principal investigator, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical UniversityHaihua Yang, MD, Principal investigator, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical UniversityYinnan Meng, MD, Principal investigator, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732430
- Sponsor's protocol ID
- YHH-201811
- Acronym
- CARTAI
- Status last verified
- Nov 2018
- First submitted
- 2 Nov 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study of CT-Guided Adaptive Radiation Therapy With Anti-PD-1 Antibody Adjuvant Immunotherapy in Patients With Thoracic Cancer (CARTAI)
- ClinicalTrials.gov ID
- NCT03732430
- Acronym / sponsor ID
- CARTAI / YHH-201811
- Conditions
- Thoracic Malignancies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Taizhou HospitalUniversity, hospital or other
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 6 Nov 2018 (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 phase II study is to evaluate the safety and efficacy of CT-based adaptive radiation therapy followed by adjuvant anti-PD-1 antibody immunotherapy in treating patients with different types and stages of thoracic malignancies. (CARTAI)
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the safety and toxicity of anti-programmed cell death 1 (PD-1) inhibition consolidation therapy after radiation therapy for multiple thoracic malignancies.
SECONDARY OBJECTIVES:
- To assess the efficacy of adjuvant anti-PD-1 antibody immunotherapy after radiotherapy.
II. To understand the dynamics and interactions of IDO with others immune pathway biomarkers.
III. To evaluate whether IDO immune status could predict the treatment outcomes of radiation and immune combined therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-PD-1 antibody | Experimental | Drug: IBI308IBI308 200mg intravenous drip every three weeks following adaptive radiation therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed inform consent form
- Age >= 18 years and <= 75 years
- Histologically or cytologically confirmed advanced/metastatic thoracic malignancies
- Patients must receive adaptive radiation therapy within 45 days before the first dose of trial treatment
- Eastern Cooperative Oncology Group performance status of 0 or 1
Key exclusion criteria (11 listed)
- Prior exposure to any immune checkpoint inhibitors including but not limited to anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibodies.
- Prior exposure to any other thoracic radiation therapy before this time radiation therapy.
- Prior exposure to steroid therapy or any other form of immunosuppressive therapy within 14 days before the first dose of trial treatment
- No active second cancers
- Active or prior autoimmune disease or immunodeficiency.
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 |
|---|---|---|
| IBI308A humanized anti-PD-1 monoclonal antibody | Drug | Anti-PD-1 antibody |
Primary outcome
AEs and SAEs at 6 months
Time frame: 6 months
Number of participants with adverse events and serious adverse events at 6 months will be measured. [CTCAE v4.03]
5 secondary outcomes
ORR
Time frame: Estimated to be up to 3 years
DoR
Time frame: Estimated to be up to 3 years
AEs
Time frame: Estimated to be up to 3 years
PFS
Time frame: Estimated to be up to 3 years
OS
Time frame: Estimated to be up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Fengming (Spring) Kong, MD principal investigator
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Haihua Yang, MD principal investigator
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Yinnan Meng, MD principal investigator
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
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 IBI308 in people with Thoracic Malignancies, run by Taizhou 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 7 inclusion and 11 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 Nov 2018. 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 Haihua Yang, MD (+86 13819639006, yhh93181@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs and SAEs at 6 months (time frame: 6 months). 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 Nov 2018.