Trial · NCT03558191
SHR-1210 in Recurrent/Metastatic Nasopharyngeal Carcinoma Who Have Received Previous At Least Two Lines of Chemotherapy.
NCT03558191, Phase 2, Completed, Jiangsu HengRui Medicine Co., Ltd.; results first posted 2024-03-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. SHR-1210 in Recurrent/Metastatic Nasopharyngeal Carcinoma Who Have Received Previous At Least Two Lines of Chemotherapy. Trials, record NCT03558191. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03558191
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SHR-1210 in Recurrent/Metastatic Nasopharyngeal Carcinoma Who Have Received Previous At Least Two Lines of Chemotherapy.
- NCT number
- NCT03558191
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 156 participants, actual
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Conditions
- Nasopharyngeal Carcinoma
- Interventions
- SHR-1210
- First posted
- 2018-06-15
- Last updated
- 2024-03-15
- Results first posted
- 2024-03-15
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) Assess by Independent Review Committee (IRC) | Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death ，whichever was earlier, approximately 3 years. | Percentage of participants achieved partial response (PR) or complete response (CR) based on IRC assessment according to the RECIST (version 1.1) is presented for this endpoint. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks (28 days) after the criteria for response are first met. Only tumor assessments performed on or before the start date of any further anti-cancer therapies are considered in the assessment of best overall response . |
| Secondary | ORR Assess by Investigators | Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years. | Percentage of participants achieved partial response (PR) or complete response (CR) based on investigator assessment according to the RECIST (version 1.1) is presented for this endpoint. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks (28 days) after the criteria for response are first met. Only tumor assessments performed on or before the start date of any further anti-cancer therapies are considered in the assessment of best overall response. |
| Secondary | Duration of Response (DoR) | Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years. | DoR is defined, for participants with a CR or PR per RECIST version 1.1, as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or death, whichever occurs first. |
| Secondary | Disease Control Rate (DCR) | Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years. | Percentage of participants achieving PR, CR or SD (SD ≥ 8 weeks) based on IRC assessment according to the RECIST version 1.1 is presented in this endpoint. DCR is a best overall response from the time of first dose to the documented objective progression or the subsequent anti-tumor therapy (whichever occurs first). |
| Secondary | Progression-Free Survival (PFS) | Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years. | PFS is defined as the time from the first dose to the date of the first documentation of PD or death, whichever occurs first. PFS was based on investigator assessment according to the RECIST version 1.1. PFS time was summarized using the Kaplan-Meier method. |
| Secondary | Overall Survival (OS) | Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years. | Overall Survival is defined as the time from the first dose to death due to any cause. OS time was measured using the Kaplan-Meier method. |
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 | Objective Response Rate (ORR) Assess by Independent Review Committee (IRC) | Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death ，whichever was earlier, approximately 3 years. | The primary efficacy endpoint was analyzed in FAS. | percentage of participants | NUMBER |
| SECONDARY | ORR Assess by Investigators | Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years. | The secondary efficacy endpoint was analyzed in FAS. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DoR) | Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years. | The secondary efficacy endpoint was analyzed in FAS. | month | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years. | The secondary efficacy endpoint was analyzed in FAS. | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years. | The secondary efficacy endpoint was analyzed in FAS. | month | MEDIAN |
| SECONDARY | Overall Survival (OS) | Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years. | The secondary efficacy endpoint was analyzed in FAS. | month | MEDIAN |
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 |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) Assess by Independent Review Committee (IRC) | SHR-1210 Injection | 28.3 | 95% Confidence Interval 21.3 to 36.2 | percentage of participants | |
| ORR Assess by Investigators | SHR-1210 Injection | 24.3 | 95% Confidence Interval 17.8 to 32.0 | percentage of participants | |
| Duration of Response (DoR) | SHR-1210 Injection | 20.3 | 95% Confidence Interval 13.0 to 30.5 | month | |
| Disease Control Rate (DCR) | SHR-1210 Injection | 54.6 | 95% Confidence Interval 46.3 to 62.7 | percentage of participants | |
| Progression-Free Survival (PFS) | SHR-1210 Injection | 3.7 | 95% Confidence Interval 2.0 to 5.4 | month | |
| Overall Survival (OS) | SHR-1210 Injection | 18.7 | 95% Confidence Interval 15.2 to 20.1 | month |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SHR-1210 Injection | 156 | |
| Overall Study | Treated | SHR-1210 Injection | 156 | |
| Overall Study | COMPLETED | SHR-1210 Injection | 131 | |
| Overall Study | NOT COMPLETED | SHR-1210 Injection | 25 |
Source ClinicalTrials.gov
Adverse events90
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 | SHR-1210 Injection | 82 | 156 | |
| other | Hypothyroidism | Endocrine disorders | SHR-1210 Injection | 42 | 156 | |
| other | Constipation | Gastrointestinal disorders | SHR-1210 Injection | 28 | 156 | |
| other | Vomiting | Gastrointestinal disorders | SHR-1210 Injection | 12 | 156 | |
| other | Diarrhoea | Gastrointestinal disorders | SHR-1210 Injection | 11 | 156 | |
| other | Abdominal pain | Gastrointestinal disorders | SHR-1210 Injection | 10 | 156 | |
| other | Dry mouth | Gastrointestinal disorders | SHR-1210 Injection | 10 | 156 | |
| other | Nausea | Gastrointestinal disorders | SHR-1210 Injection | 10 | 156 | |
| other | Pyrexia | General disorders | SHR-1210 Injection | 39 | 156 | |
| other | Asthenia | General disorders | SHR-1210 Injection | 35 | 156 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SHR-1210 Injection | 11 | 156 |
| Total, other adverse events | SHR-1210 Injection | 154 | 156 |
| Total, serious adverse events | SHR-1210 Injection | 37 | 156 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37409613 | 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/NCT03558191
GET https://conductscience.org/api/trials/v1/NCT03558191/events?page=2