Trial · NCT03092895

A Study of SHR-1210 in Combination With Apatinib or Chemotherapy in Subjects With Advanced PLC or BTC

NCT03092895, Phase 2, Completed, Jiangsu HengRui Medicine Co., Ltd.; results first posted 2026-01-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of SHR-1210 in Combination With Apatinib or Chemotherapy in Subjects With Advanced PLC or BTC. Trials, record NCT03092895. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03092895

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of SHR-1210 in Combination With Apatinib or Chemotherapy in Subjects With Advanced PLC or BTC
NCT number: NCT03092895
Status: Completed
Phases: Phase 2
Enrollment: 157 participants, actual
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Conditions: Advanced Primary Liver Cancer, Advanced Biliary Tract Carcinoma
Interventions: SHR-1210, Apatinib, FOLFOX4, GEMOX
First posted: 2017-03-28
Last updated: 2026-01-29
Results first posted: 2026-01-29

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Safety and Tolerability	Up to approximately 4 years	The incidence of adverse events (AEs) and Serious adverse events (SAEs) assessed by NCI-CTCAE v4.03
Secondary	Objective Response Rate (ORR)	Up to approximately 4 years	Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) assessed by investigator: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Secondary	Duration of Response (DoR)	Up to approximately 4 years	The time from the date of the first recorded objective tumor response (assessed as per RECIST V1.1) to the date of the first recorded objective tumor progression (assessed as per RECIST V1.1) or the date of death due to any cause, whichever occurs first, in subjects with a BOR of CR or PR.
Secondary	Disease Control Rate (DCR)	Up to approximately 4 years	The percentage of subjects with a BOR of CR, PR, and SD as per RECIST V1.1. BOR of CR or PR must be confirmed at least 4 weeks (28 days) after the initial assessment.
Secondary	Time to Progression (TTP)	Up to approximately 4 years	The time from the date of the first dose to the date of radiographic PD (assessed by the investigator as per RECIST V1.1).PD is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or significant progression of non-target lesions leading to discontinuation of therapy, or the appearance of new lesions.
Secondary	Overall Survival	Up to approximately 4 years	The time from the date of the first dose to death due to any cause. Overal Survial will be calculated based on Kaplan-Meier estimates
Secondary	Time to Response (TTR)	Up to approximately 4 years	The time from the date of the first dose to the date of the first recorded tumor response (assessed as per RECIST V1.1) in subjects with a BOR of CR or PR.
Secondary	Progression-free Survival (PFS)	Up to approximately 4 years	The time from the date of the first dose to the date of the first recorded tumor progression (assessed as per RECIST V1.1) or the date of death due to any cause, whichever occurs first.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Safety and Tolerability	Up to approximately 4 years	The primary safety endpoint was analyzed in SS. The SS included all participants who were treated .	participants	NUMBER
SECONDARY	Objective Response Rate (ORR)	Up to approximately 4 years	The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were treated.	percentage of participants	NUMBER
SECONDARY	Duration of Response (DoR)	Up to approximately 4 years	The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were treated.	months	MEDIAN
SECONDARY	Disease Control Rate (DCR)	Up to approximately 4 years	The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were treated.	percentage of participants	NUMBER
SECONDARY	Time to Progression (TTP)	Up to approximately 4 years	The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were treated.	months	MEDIAN
SECONDARY	Overall Survival	Up to approximately 4 years	The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were treated.	months	MEDIAN
SECONDARY	Time to Response (TTR)	Up to approximately 4 years	The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were treated.	months	MEDIAN
SECONDARY	Progression-free Survival (PFS)	Up to approximately 4 years	The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were treated.	months	MEDIAN

Source ClinicalTrials.gov

Results by group36

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
The Safety and Tolerability	Arm A：SHR-1210+Apatinib	Number of Subjects with AEs	28		participants
The Safety and Tolerability	Arm B：Hepatocellular Carcinoma(SHR-1210 + FOLFOX4 Q2W)	Number of Subjects with AEs	34		participants
The Safety and Tolerability	Arm B：Cholangiocarcinoma（SHR-1210 + FOLFOX4 Q2W or SHR-1210 + GEMOX Q2W)	Number of Subjects with AEs	92		participants
The Safety and Tolerability	Arm B：Others	Number of Subjects with AEs	3		participants
The Safety and Tolerability	Arm A：SHR-1210+Apatinib	Number of Subjects with SAEs	14		participants
The Safety and Tolerability	Arm B：Hepatocellular Carcinoma(SHR-1210 + FOLFOX4 Q2W)	Number of Subjects with SAEs	20		participants
The Safety and Tolerability	Arm B：Cholangiocarcinoma（SHR-1210 + FOLFOX4 Q2W or SHR-1210 + GEMOX Q2W)	Number of Subjects with SAEs	58		participants
The Safety and Tolerability	Arm B：Others	Number of Subjects with SAEs	2		participants
Objective Response Rate (ORR)	Arm A：SHR-1210+Apatinib		10.7	95% Confidence Interval 2.3 to 28.2	percentage of participants
Objective Response Rate (ORR)	Arm B：Hepatocellular Carcinoma(SHR-1210+ FOLFOX4 Q2W)		29.4	95% Confidence Interval 15.1 to 47.5	percentage of participants

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A：SHR-1210+Apatinib	28
Overall Study	STARTED	Arm B：Hepatocellular Carcinoma(SHR-1210 + FOLFOX4 Q2W)	34
Overall Study	STARTED	Arm B：Cholangiocarcinoma（SHR-1210 + FOLFOX4 Q2W or SHR-1210 + GEMOX Q2W)	92
Overall Study	STARTED	Arm B：Others	3
Overall Study	COMPLETED	Arm A：SHR-1210+Apatinib	28
Overall Study	COMPLETED	Arm B：Hepatocellular Carcinoma(SHR-1210 + FOLFOX4 Q2W)	34
Overall Study	COMPLETED	Arm B：Cholangiocarcinoma（SHR-1210 + FOLFOX4 Q2W or SHR-1210 + GEMOX Q2W)	92
Overall Study	COMPLETED	Arm B：Others	3
Overall Study	NOT COMPLETED	Arm A：SHR-1210+Apatinib	0
Overall Study	NOT COMPLETED	Arm B：Hepatocellular Carcinoma(SHR-1210 + FOLFOX4 Q2W)	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events648

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
other	Anaemia	Blood and lymphatic system disorders	Arm A：SHR-1210+Apatinib	6	28
other	Anaemia	Blood and lymphatic system disorders	Arm B：Hepatocellular Carcinoma(SHR-1210 + FOLFOX4 Q2W)	13	34
other	Anaemia	Blood and lymphatic system disorders	Arm B：Cholangiocarcinoma（SHR-1210 + FOLFOX4 Q2W or SHR-1210 + GEMOX Q2W)	45	92
other	Anaemia	Blood and lymphatic system disorders	Arm B：Others	0	3
other	Sinus tachycardia	Cardiac disorders	Arm A：SHR-1210+Apatinib	1	28
other	Sinus tachycardia	Cardiac disorders	Arm B：Hepatocellular Carcinoma(SHR-1210 + FOLFOX4 Q2W)	1	34
other	Sinus tachycardia	Cardiac disorders	Arm B：Cholangiocarcinoma（SHR-1210 + FOLFOX4 Q2W or SHR-1210 + GEMOX Q2W)	6	92
other	Sinus tachycardia	Cardiac disorders	Arm B：Others	0	3
other	Hypothyroidism	Endocrine disorders	Arm A：SHR-1210+Apatinib	8	28
other	Hypothyroidism	Endocrine disorders	Arm B：Hepatocellular Carcinoma(SHR-1210 + FOLFOX4 Q2W)	5	34

1 to 10 of 648Source ClinicalTrials.gov

See all 648 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A：SHR-1210+Apatinib	11	28
Total, all-cause mortality	Arm B：Hepatocellular Carcinoma(SHR-1210 + FOLFOX4 Q2W)	11	34
Total, all-cause mortality	Arm B：Cholangiocarcinoma（SHR-1210 + FOLFOX4 Q2W or SHR-1210 + GEMOX Q2W)	35	92
Total, all-cause mortality	Arm B：Others	1	3
Total, other adverse events	Arm A：SHR-1210+Apatinib	28	28
Total, other adverse events	Arm B：Hepatocellular Carcinoma(SHR-1210 + FOLFOX4 Q2W)	34	34
Total, other adverse events	Arm B：Cholangiocarcinoma（SHR-1210 + FOLFOX4 Q2W or SHR-1210 + GEMOX Q2W)	92	92
Total, other adverse events	Arm B：Others	3	3
Total, serious adverse events	Arm A：SHR-1210+Apatinib	14	28
Total, serious adverse events	Arm B：Hepatocellular Carcinoma(SHR-1210 + FOLFOX4 Q2W)	20	34

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33741732	DERIVED	PubMed
34309846	DERIVED	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03092895

GET https://conductscience.org/api/trials/v1/NCT03092895/results?page=2

API reference For AI assistants