Trial · NCT03155425
PD-1 Antibody SHR-1210 in Patients With Relapsed or Refractory Classic Hodgkin's Lymphoma
NCT03155425, Phase 2, Completed, Jiangsu HengRui Medicine Co., Ltd.; results first posted 2024-02-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PD-1 Antibody SHR-1210 in Patients With Relapsed or Refractory Classic Hodgkin's Lymphoma. Trials, record NCT03155425. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03155425
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PD-1 Antibody SHR-1210 in Patients With Relapsed or Refractory Classic Hodgkin's Lymphoma
- NCT number
- NCT03155425
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 75 participants, actual
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Conditions
- Hodgkin Lymphoma, Adult
- Interventions
- SHR-1210
- First posted
- 2017-05-16
- Last updated
- 2024-02-01
- Results first posted
- 2024-02-01
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ORR Assess by IRC | CT was conducted at baseline, at weeks 9, 17, 25, 37, 49, 65, 81, and 97, and then every 26 weeks; PET was conducted at baseline, weeks 17 and 25. ORR of 36 weeks based on CT and PET were reported. | rate of subjects achieved complete response plus partial response in all evaluable subjects (Response was assessed with CT and PET using 2014 Lugano Criteria for Malignant Lymphomas, CR is disappearance of all tumor lesions, PR is over 50% decrease of the sum of the product of the perpendicular diameters from baseline ;overall response:PR+CR) |
| Secondary | DoR Assess by IRC | CT was conducted at baseline, at weeks 9, 17, 25, 37, 49, 65, 81, and 97, and then every 26 weeks; PET was conducted at baseline, weeks 17 and 25. DoR of 36 weeks based on CT and PET were reported. | Duration of Response (Response was assessed with CT and PET using 2014 Lugano Criteria for Malignant Lymphomas, disease progression is over 50% increase of an product of perpendicular diameters of any target lesion from nadir with any diameter increased over 0.5cm for lesions \<=2cm or increased by 1cm for lesions \>2cm，or appearance of new lesions, or progression of non-target lesion ) |
| Secondary | PFS Assess by IRC | Up to 3 years | Progression-free Survival (Response was assessed with CT and PET using 2014 Lugano Criteria for Malignant Lymphomas, disease progression is over 50% increase of an product of perpendicular diameters of any target lesion from nadir with any diameter increased over 0.5cm for lesions \<=2cm or increased by 1cm for lesions \>2cm，or appearance of new lesions, or progression of non-target lesion ) |
| Secondary | TTR Assess by IRC | CT was conducted at baseline, at weeks 9, 17, 25, 37, 49, 65, 81, and 97, and then every 26 weeks; PET was conducted at baseline, weeks 17 and 25. | Time to response (Response was assessed with CT and PET using 2014 Lugano Criteria for Malignant Lymphomas, CR is disappearance of all tumor lesions, PR is over 50% decrease of the sum of the product of the perpendicular diameters from baseline ;overall response:PR+CR) |
| Secondary | OS | Up to 3 years | Overall Survival |
| Secondary | Incidence and Severity of Adverse Events (AE) | Up to 3 years |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | ORR Assess by IRC | CT was conducted at baseline, at weeks 9, 17, 25, 37, 49, 65, 81, and 97, and then every 26 weeks; PET was conducted at baseline, weeks 17 and 25. ORR of 36 weeks based on CT and PET were reported. | percentage | NUMBER | |
| SECONDARY | DoR Assess by IRC | CT was conducted at baseline, at weeks 9, 17, 25, 37, 49, 65, 81, and 97, and then every 26 weeks; PET was conducted at baseline, weeks 17 and 25. DoR of 36 weeks based on CT and PET were reported. | months | MEDIAN | |
| SECONDARY | PFS Assess by IRC | Up to 3 years | months | MEDIAN | |
| SECONDARY | TTR Assess by IRC | CT was conducted at baseline, at weeks 9, 17, 25, 37, 49, 65, 81, and 97, and then every 26 weeks; PET was conducted at baseline, weeks 17 and 25. | months | MEDIAN | |
| SECONDARY | OS | Up to 3 years | months | MEDIAN | |
| SECONDARY | Incidence and Severity of Adverse Events (AE) | Up to 3 years | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| ORR Assess by IRC | Injection SHR-1210 | 76.0 | 95% Confidence Interval 64.7 to 85.1 | percentage | |
| DoR Assess by IRC | Injection SHR-1210 | 31.7 | 95% Confidence Interval 16.7 to NA | months | |
| PFS Assess by IRC | Injection SHR-1210 | 22.5 | 95% Confidence Interval 14.7 to NA | months | |
| TTR Assess by IRC | Injection SHR-1210 | 2.0 | Full Range 1.7 to 5.7 | months | |
| OS | Injection SHR-1210 | NA | 95% Confidence Interval NA to NA | months | |
| Incidence and Severity of Adverse Events (AE) | Injection SHR-1210 | 75 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Injection SHR-1210 | 75 | |
| Overall Study | COMPLETED | Injection SHR-1210 | 75 | |
| Overall Study | NOT COMPLETED | Injection SHR-1210 | 0 |
Source ClinicalTrials.gov
Adverse events62
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Injection SHR-1210 | 17 | 75 | |
| other | Arrhythmia | Cardiac disorders | Injection SHR-1210 | 4 | 75 | |
| other | Hypothyroidism | Endocrine disorders | Injection SHR-1210 | 24 | 75 | |
| other | Hyperthyroidism | Endocrine disorders | Injection SHR-1210 | 5 | 75 | |
| other | Diarrhoea | Gastrointestinal disorders | Injection SHR-1210 | 8 | 75 | |
| other | Pyrexia | General disorders | Injection SHR-1210 | 33 | 75 | |
| other | Asthenia | General disorders | Injection SHR-1210 | 6 | 75 | |
| other | Reactive angioendotheliomatosis | Immune system disorders | Injection SHR-1210 | 73 | 75 | |
| other | Upper respiratory tract infection | Infections and infestations | Injection SHR-1210 | 41 | 75 | |
| other | Nasopharyngitis | Infections and infestations | Injection SHR-1210 | 12 | 75 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Injection SHR-1210 | 0 | 75 |
| Total, other adverse events | Injection SHR-1210 | 74 | 75 |
| Total, serious adverse events | Injection SHR-1210 | 12 | 75 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31420358 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03155425
GET https://conductscience.org/api/trials/v1/NCT03155425/events?page=2