Solid TumorPhase 2NCT04346381

Study to Evaluate the Efficacy and Safety of Camrelizumab and Famitinib in Patients With Advanced Solid Tumor

A Phase 2 study testing Camrelizumab and Famitinib in people with Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is an open-label, multi-center study to evaluate the anti-tumor activity and safety of camrelizumab combined famitinib in subjects with selected advanced solid tumor. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Solid Tumor
What is being tested?: Camrelizumab and Famitinib
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 233 participants
Where: 1 siteChina
Study dates: 5 Jun 2020to 22 Jun 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

Histologically- or cytologically-confirmed diagnosis of advanced solid tumor.
Willing to provide tumor tissue for PD-L1 biomarker analysis.
At least one measurable lesion according to RECIST 1.1.
ECOG performance status of 0 to 1.
Life expectancy of more than 12 weeks.
Signing the informed consent forms.
Adequate bone marrow, liver and renal function.

Who cannot join

Subjects with untreated central nervous system (CNS) metastases.
Subjects with an active, known or suspected autoimmune disease.
Subjects with clinically significant cardiovascular and cerebrovascular diseases.
Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs.
Subjects with previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency.
Subjects with arterial / venous thrombosis events occurred within 6 months of the first dose.
Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody, and VEGFR small molecule inhibitor therapy.

Trial locations and contacts

1 site in 1 country.

China1 site

Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: An Open-label, Multi-center，Phase II Study of Camrelizumab Combined With Famitinib in the Treatment of Advanced Solid Tumor

This is an open-label, multi-center study to evaluate the anti-tumor activity and safety of camrelizumab combined famitinib in subjects with selected advanced solid tumor.

Conditions: Solid Tumor
Being tested: Camrelizumab, Famitinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CamrelizumabDrug
Also called SHR-1210
Intravenous (IV) camrelizumab on Day 1 of each cycle
FamitinibDrug
famitinib po qd

Study groups in NCT04346381
Study group	Role	What they receive
camrelizumab combined with famitinib	Experimental	Participants will receive camrelizumab on Day 1of each cycle and famitinib qd up to 2 years. Receives: Drug: Camrelizumab; Drug: Famitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Response Rate
Response Rate
Measured: Up to 18 months

Secondary outcomes (10)

PFS
Progression-free Survival
Measured: Up to 18 months
DOR
Duration of Response
Measured: Up to 18months
DCR
Disease Control Rate
Measured: Up to 18months
TTR
Time to Response
Measured: Up to 18 months
OS
overall survival rate
Measured: Up to 18 months
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0 (SAEs) as assessed by CTCAE v5.0
Measured: Up to 18 months
Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities.
Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities.
Measured: Up to 18 months
Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline
Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline
Measured: Up to 18 months
Serum concentration of camrelizumab
Serum concentration of camrelizumab
Measured: Up to 18 months
Plasma concentration of famitinib
Plasma concentration of famitinib
Measured: Up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jun 202022 Jun 2022

First posted15 Apr 2020
Study start5 Jun 2020
Primary completion22 Jun 2022
Study completion22 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Solid TumorStudies of the same condition, open and under way.
More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
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: 233 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04346381
Sponsor's protocol ID: SHR-1210-II-215
Status last verified: Sep 2023
First submitted: 10 Apr 2020
Last updated: 18 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Xu B, Zhu G, Lu J, Zhang X, Chen X, Liu Q, Qu S, Fan J, Liu T. Camrelizumab Plus Famitinib in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: A Phase 2 Study. Cancer Med. 2026 May;15(5):e71899. doi: 10.1002/cam4.71899.
PubMed 42165088
Ai L, Li Q, Zhang S, Dong Y, Yang M, Li J, Pan Y, Yuan Y, Yi S, Wang J, Cheng Y, Feng J, Gao S, Wang X, Qu S, Zhang X, Lu J, Xiu P, Wang S, Yang X, Yu Y, Liu T. Famitinib plus camrelizumab in patients with advanced colorectal cancer: Data from a multicenter, basket study. Innovation (Camb). 2025 Jan 6;6(1):100745. doi: 10.1016/j.xinn.2024.100745. eCollection 2025 Jan 6.
PubMed 39872476
Ren S, Wang X, Han BH, Pan Y, Zhao J, Cheng Y, Hu S, Liu T, Li Y, Cheng Y, Feng J, Yi S, Gu S, Gao S, Luo Y, Liu Y, Liu C, Duan H, Wang S, Yang X, Fan J, Zhou C. First-line treatment with camrelizumab plus famitinib in advanced or metastatic NSCLC patients with PD-L1 TPS >/=1%: results from a multicenter, open-label, phase 2 trial. J Immunother Cancer. 2024 Feb 21;12(2):e007227. doi: 10.1136/jitc-2023-007227.
PubMed 38388167
Ding X, Hua YJ, Zou X, Chen XZ, Zhang XM, Xu B, Ouyang YF, Tu ZW, Li HF, Duan CY, Zhang WJ, You R, Liu YP, Liu YL, Yang Q, Huang PY, Wang SN, Fan J, Chen MY. Camrelizumab plus famitinib in patients with recurrent or metastatic nasopharyngeal carcinoma treated with PD-1 blockade: data from a multicohort phase 2 study. EClinicalMedicine. 2023 Jun 23;61:102043. doi: 10.1016/j.eclinm.2023.102043. eCollection 2023 Jul.
PubMed 37415845

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Multi-center，Phase II Study of Camrelizumab Combined With Famitinib in the Treatment of Advanced Solid Tumor
ClinicalTrials.gov ID: NCT04346381
Acronym / sponsor ID: SHR-1210-II-215
Conditions: Solid Tumor
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 233 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 5 Jun 2020 (actual)
Primary completion: 22 Jun 2022 (actual)
Study completion: 22 Jun 2022 (actual)
First posted: 15 Apr 2020 (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 is an open-label, multi-center study to evaluate the anti-tumor activity and safety of camrelizumab combined famitinib in subjects with selected advanced solid tumor.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
camrelizumab combined with famitinib	Experimental	Drug: Camrelizumab, Drug: FamitinibParticipants will receive camrelizumab on Day 1of each cycle and famitinib qd up to 2 years.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Histologically- or cytologically-confirmed diagnosis of advanced solid tumor.
Willing to provide tumor tissue for PD-L1 biomarker analysis.
At least one measurable lesion according to RECIST 1.1.
ECOG performance status of 0 to 1.
Life expectancy of more than 12 weeks.

Key exclusion criteria (7 listed)

Subjects with untreated central nervous system (CNS) metastases.
Subjects with an active, known or suspected autoimmune disease.
Subjects with clinically significant cardiovascular and cerebrovascular diseases.
Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs.
Subjects with previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency.

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
CamrelizumabAlso: SHR-1210Intravenous (IV) camrelizumab on Day 1 of each cycle	Drug	camrelizumab combined with famitinib
Famitinibfamitinib po qd	Drug	camrelizumab combined with famitinib

Primary outcome

Response Rate
Time frame: Up to 18 months
Response Rate

10 secondary outcomes

PFS
Time frame: Up to 18 months
DOR
Time frame: Up to 18months
DCR
Time frame: Up to 18months
TTR
Time frame: Up to 18 months
OS
Time frame: Up to 18 months
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0
Time frame: Up to 18 months
Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities.
Time frame: Up to 18 months
Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline
Time frame: Up to 18 months
Serum concentration of camrelizumab
Time frame: Up to 18 months
Plasma concentration of famitinib
Time frame: Up to 18 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
Derived from this study: PubMed 42165088Xu B, Zhu G, Lu J, Zhang X, Chen X, Liu Q, Qu S, Fan J, Liu T. Camrelizumab Plus Famitinib in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: A Phase 2 Study. Cancer Med. 2026 May;15(5):e71899. doi: 10.1002/cam4.71899.
Derived from this study: PubMed 39872476Ai L, Li Q, Zhang S, Dong Y, Yang M, Li J, Pan Y, Yuan Y, Yi S, Wang J, Cheng Y, Feng J, Gao S, Wang X, Qu S, Zhang X, Lu J, Xiu P, Wang S, Yang X, Yu Y, Liu T. Famitinib plus camrelizumab in patients with advanced colorectal cancer: Data from a multicenter, basket study. Innovation (Camb). 2025 Jan 6;6(1):100745. doi: 10.1016/j.xinn.2024.100745. eCollection 2025 Jan 6.
Derived from this study: PubMed 38388167Ren S, Wang X, Han BH, Pan Y, Zhao J, Cheng Y, Hu S, Liu T, Li Y, Cheng Y, Feng J, Yi S, Gu S, Gao S, Luo Y, Liu Y, Liu C, Duan H, Wang S, Yang X, Fan J, Zhou C. First-line treatment with camrelizumab plus famitinib in advanced or metastatic NSCLC patients with PD-L1 TPS >/=1%: results from a multicenter, open-label, phase 2 trial. J Immunother Cancer. 2024 Feb 21;12(2):e007227. doi: 10.1136/jitc-2023-007227.
Derived from this study: PubMed 37415845Ding X, Hua YJ, Zou X, Chen XZ, Zhang XM, Xu B, Ouyang YF, Tu ZW, Li HF, Duan CY, Zhang WJ, You R, Liu YP, Liu YL, Yang Q, Huang PY, Wang SN, Fan J, Chen MY. Camrelizumab plus famitinib in patients with recurrent or metastatic nasopharyngeal carcinoma treated with PD-1 blockade: data from a multicohort phase 2 study. EClinicalMedicine. 2023 Jun 23;61:102043. doi: 10.1016/j.eclinm.2023.102043. eCollection 2023 Jul.
Individual participant dataSharing planned: Undecided

Related trials for Solid Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

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.

The record lists no contact. Use the official record to reach the sponsor.

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 Camrelizumab and Famitinib in people with Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. 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 7 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: finished, as of the sponsor's last update on 18 Sep 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rate (time frame: Up to 18 months). 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 NCT04346381, which also lists 4 linked publications.

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 18 Sep 2023.