Early-stagePhase 2NCT05149170
Radiotherapy and Anti-PD-1 in Low-risk ES-ENKTCL
A Phase 2 study testing Anti-PD-1 monoclonal antibody in people with Early-stage and Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of adding Anti-PD-1 antibody in an inductive and concurrent way to radiotherapy in early-stage low-risk extranodal NK/T cell lymphoma, nasal type Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Early-stage, Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type
- What is being tested?
- Anti-PD-1 monoclonal antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 30 Sep 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proved extranodal NK/T cell lymphoma
- No previous anti-cancer treatment
- Measurable lesion on baseline PET/CT and MRI
- Stage I
- Normal serum LDH level
- Primary tumor invasion (PTI) absence
- ECOG PS 0-1
- Sufficient organ functions
Who cannot join
- Other mature T- or NK- lymphoma
- Hemophagocytic lymphohistiocytosis
- Primary CNS lymphoma or CNS-involved lymphoma
- History of malignancy except for cutaneous basal-/squamous- cell carcinoma or cervical carcinoma in situ 3 years prior to study treatment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Shunan Qi, MD, +861087788995, medata@163.com
About this study
Official title: Radiotherapy With Inductive and Concurrent Anti-PD-1 Antibody in Early-stage Low-risk Extranodal NK/T Cell Lymphoma, Nasal Type: A Multi-center Phase II Study
The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of adding Anti-PD-1 antibody in an inductive and concurrent way to radiotherapy in early-stage low-risk extranodal NK/T cell lymphoma, nasal type
- Being tested
- Anti-PD-1 monoclonal antibody
- Keywords
- NK/T-Cell Lymphoma, Nasal and Nasal-Type, radiotherapy, Anti-PD-1 Antibody
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-PD-1 monoclonal antibodyDrug
Also called radiotherapy
inductive Anti-PD-1 antibody + concurrent Anti-PD-1 antibody with RT
| Study group | Role | What they receive |
|---|---|---|
| Inductive and concurrent anti-PD-1 antibody combined with radiotherapy | Experimental | All the enrolled patients receive 2 doses of inductive anti-PD-1 antibody (Tislelizumab 200mg) every two weeks, and then Involved-site radiotherapy (50±6-10 Gy) with concurrent anti-PD-1 antibody (Tislelizumab 200mg) every two weeks. Receives: Drug: Anti-PD-1 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Complete response after inductive therapy
complete resolution of disease in imaging and biopsy after inductive therapy
Measured: 2-4 weeks after inductive anti-PD-1 antibody
Secondary outcomes (5)
Progression-free survival rate at year 2 after enrollment, 2y-PFS
From enrollment to any disease progression or death
Measured: 2-year
Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS
From enrollment to death
Measured: 2-year, 5-year
Rate of acute toxicity (any and above grade 3)
toxicities according to CTCAE criteria
Measured: From enrollment to 3 months after treatment
Quality of Life change, QoL
measurement basing on EORTC-QLQ-HN35 tables
Measured: baseline, 1/3/6/12/24 months after treatment
Quality of Life change, QoL
measurement basing on EORTC-QLQ-C30 tables
Measured: baseline, 1/3/6/12/24 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Oct 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early-stageStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, The First Hospital of Jilin University, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Responsible party
- Principal investigator, Shunan Qi, Chinese Academy of Medical Sciences
- Investigators
- Ye-Xiong Li, MD, Principal investigator, CAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149170
- Sponsor's protocol ID
- CLCG-NKT-2101
- Status last verified
- Dec 2021
- First submitted
- 6 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Li JY, Qi SN, Hu C, Liu X, Yang Y, Wu T, Zheng R, Feng XL, Ni XG, Jin FY, Song YQ, Liu WP, Zhou SY, Li YX. Tislelizumab and radiation therapy in low-risk early-stage extranodal natural killer/T-cell lymphoma, nasal type: a phase II study protocol. Future Oncol. 2024 Feb;20(5):245-256. doi: 10.2217/fon-2023-0065. Epub 2023 Nov 29.
PubMed 38018460
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiotherapy With Inductive and Concurrent Anti-PD-1 Antibody in Early-stage Low-risk Extranodal NK/T Cell Lymphoma, Nasal Type: A Multi-center Phase II Study
- ClinicalTrials.gov ID
- NCT05149170
- Acronym / sponsor ID
- CLCG-NKT-2101
- Keywords
- NK/T-Cell Lymphoma, Nasal and Nasal-Type, radiotherapy, Anti-PD-1 Antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, The First Hospital of Jilin University, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 8 Dec 2021 (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.
The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of adding Anti-PD-1 antibody in an inductive and concurrent way to radiotherapy in early-stage low-risk extranodal NK/T cell lymphoma, nasal type
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inductive and concurrent anti-PD-1 antibody combined with radiotherapy | Experimental | Drug: Anti-PD-1 monoclonal antibodyAll the enrolled patients receive 2 doses of inductive anti-PD-1 antibody (Tislelizumab 200mg) every two weeks, and then Involved-site radiotherapy (50±6-10 Gy) with concurrent anti-PD-1 antibody (Tislelizumab 200mg) every two weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Biopsy proved extranodal NK/T cell lymphoma
- No previous anti-cancer treatment
- Measurable lesion on baseline PET/CT and MRI
- Stage I
- Normal serum LDH level
Key exclusion criteria (4 listed)
- Other mature T- or NK- lymphoma
- Hemophagocytic lymphohistiocytosis
- Primary CNS lymphoma or CNS-involved lymphoma
- History of malignancy except for cutaneous basal-/squamous- cell carcinoma or cervical carcinoma in situ 3 years prior to study treatment
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 |
|---|---|---|
| Anti-PD-1 monoclonal antibodyAlso: radiotherapyinductive Anti-PD-1 antibody + concurrent Anti-PD-1 antibody with RT | Drug | Inductive and concurrent anti-PD-1 antibody combined with radiotherapy |
Primary outcome
Rate of Complete response after inductive therapy
Time frame: 2-4 weeks after inductive anti-PD-1 antibody
complete resolution of disease in imaging and biopsy after inductive therapy
5 secondary outcomes
Progression-free survival rate at year 2 after enrollment, 2y-PFS
Time frame: 2-year
Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS
Time frame: 2-year, 5-year
Rate of acute toxicity (any and above grade 3)
Time frame: From enrollment to 3 months after treatment
Quality of Life change, QoL
Time frame: baseline, 1/3/6/12/24 months after treatment
Quality of Life change, QoL
Time frame: baseline, 1/3/6/12/24 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Derived from this study: PubMed 38018460Li JY, Qi SN, Hu C, Liu X, Yang Y, Wu T, Zheng R, Feng XL, Ni XG, Jin FY, Song YQ, Liu WP, Zhou SY, Li YX. Tislelizumab and radiation therapy in low-risk early-stage extranodal natural killer/T-cell lymphoma, nasal type: a phase II study protocol. Future Oncol. 2024 Feb;20(5):245-256. doi: 10.2217/fon-2023-0065. Epub 2023 Nov 29.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
Ye-Xiong Li, MD principal investigator
CAMS
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 Anti-PD-1 monoclonal antibody in people with Early-stage and Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type, run by Chinese Academy of Medical Sciences 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 4 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 8 Dec 2021. 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 Shunan Qi, MD (+8610-87788995, medata@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Complete response after inductive therapy (time frame: 2-4 weeks after inductive anti-PD-1 antibody). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05149170, which also lists 1 linked publication.
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 8 Dec 2021.