Solid TumorNCT05380986
Camrelizumab Combined With Apatinib Mesylate
A study testing Camrelizumab combined with apatinib mesylate in people with Solid Tumor, run by Henan Cancer Hospital at 1 site in China.
Trial summary
The purpose of this study is to observe the safety of camrelizumab combined with apatinib mesylate in the treatment of solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Camrelizumab combined with apatinib mesylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2022to 1 May 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥18 years old, male or female;
- ECOG score is 0~2;
- Patients with solid tumors confirmed by pathology or histology;
- At least one measurable lesion (according to RECIST V 1.1);
- For patients who have failed first-line or second-line treatment or who cannot tolerate standard treatment regimens for solid tumors.
- Estimated survival ≥3 months;
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- Patients who have used immunosuppressants or antiangiogenic drugs in the past are not excluded;
- For women who have not undergone menopause or surgical sterilization, agree to abstain from sex or use an effective contraceptive method during treatment and for at least 7 months after the last dose given in study treatment;
- Researchers think they can benefit;
- Voluntarily participate in the study and sign the informed consent;
Who cannot join
- Pregnant or lactating women;
- Except patients with contraindications to camrelizumab and/or apatinib mesylate, that is, those allergic to camrelizumab and its excipients; Allergic to apatinib mesylate should be prohibited; It should be contraindication for patients with active bleeding, ulcers, intestinal perforation, intestinal obstruction, hypertension beyond drug control within 30 days after major surgery, class III-IV cardiac insufficiency (NYHA standard), and severe hepatic or renal insufficiency (Class 4).
- Those deemed unsuitable for inclusion by doctors;
- The researchers determined there was a high risk that the tumor would invade important blood vessels and cause fatal hemorrhages during the follow-up study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Tumor Hospital
Henan
LI NING, Doctor, 13526501903, lining97@126.com
About this study
Official title: A Real World Study of Camrelizumab Combined With Apatinib Mesylate in Solid Tumors
The purpose of this study is to observe the safety of camrelizumab combined with apatinib mesylate in the treatment of solid tumors
Read the detailed description
According to current studies, the combination of camrelizide and apatinib mesylate has significant efficacy and controllable toxicity in the treatment of solid tumors.
This study adopted camrelizumab combined with apatinib mesylate in the treatment of solid tumors, aiming to further explore the safety of camrelizumab combined with apatinib mesylate in the treatment of solid tumors and provide more research data for the treatment of solid tumors.
- Conditions
- Solid Tumor
- Being tested
- Camrelizumab combined with apatinib mesylate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab combined with apatinib mesylateDrug
Camrelizumab 200 mg, IVGTT D1, apatinib mesylate, once daily. The specific prescription is determined by the investigator. Continued use until disease progression, unacceptable toxicity, or withdrawal for other reasons.
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab combined with apatinib mesylate | Experimental | Camrelizumab 200 mg, IVGTT D1, apatinib mesylate, once daily. The specific prescription is determined by the investigator. Continued use until disease progression, unacceptable toxicity, or withdrawal for other reasons. Receives: Drug: Camrelizumab combined with apatinib mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE
any adverse medical event that occurs after a subject or clinical study receives a drug or treatment regimen
Measured: up to 2 years
Secondary outcomes (3)
Objective response rate
Defined as the proportion of patients with a documented complete response, and partial response (CR+PR)
Measured: up to 2 years
Disease control rate
defined as the proportion of patients with complete response, partial response and disease stabilization (CR+PR+SD)
Measured: up to 2 years
Overall survival
Overall survival
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start20 May 2022 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, LiNing, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380986
- Sponsor's protocol ID
- SHR-1210-RWS
- Status last verified
- May 2022
- First submitted
- 10 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Study of Camrelizumab Combined With Apatinib Mesylate in Solid Tumors
- ClinicalTrials.gov ID
- NCT05380986
- Acronym / sponsor ID
- SHR-1210-RWS
- Conditions
- Solid Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 20 May 2022 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 19 May 2022 (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 purpose of this study is to observe the safety of camrelizumab combined with apatinib mesylate in the treatment of solid tumors
Detailed description
According to current studies, the combination of camrelizide and apatinib mesylate has significant efficacy and controllable toxicity in the treatment of solid tumors.
This study adopted camrelizumab combined with apatinib mesylate in the treatment of solid tumors, aiming to further explore the safety of camrelizumab combined with apatinib mesylate in the treatment of solid tumors and provide more research data for the treatment of solid tumors.
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 apatinib mesylate | Experimental | Drug: Camrelizumab combined with apatinib mesylateCamrelizumab 200 mg, IVGTT D1, apatinib mesylate, once daily. The specific prescription is determined by the investigator. Continued use until disease progression, unacceptable toxicity, or withdrawal for other reasons. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: ≥18 years old, male or female;
- ECOG score is 0~2;
- Patients with solid tumors confirmed by pathology or histology;
- At least one measurable lesion (according to RECIST V 1.1);
- For patients who have failed first-line or second-line treatment or who cannot tolerate standard treatment regimens for solid tumors.
Key exclusion criteria (4 listed)
- Pregnant or lactating women;
- Except patients with contraindications to camrelizumab and/or apatinib mesylate, that is, those allergic to camrelizumab and its excipients; Allergic to apatinib mesylate should be prohibited; It should be contraindication for patients with active bleeding, ulcers, intestinal perforation, intestinal obstruction, hypertension beyond drug control within 30 days after major surgery, class III-IV cardiac insufficiency (NYHA standard), and severe hepatic or renal insufficiency (Class 4).
- Those deemed unsuitable for inclusion by doctors;
- The researchers determined there was a high risk that the tumor would invade important blood vessels and cause fatal hemorrhages during the follow-up study
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 |
|---|---|---|
| Camrelizumab combined with apatinib mesylateCamrelizumab 200 mg, IVGTT D1, apatinib mesylate, once daily. The specific prescription is determined by the investigator. Continued use until disease progression, unacceptable toxicity, or withdrawal for other reasons. | Drug | Camrelizumab combined with apatinib mesylate |
Primary outcome
AE
Time frame: up to 2 years
any adverse medical event that occurs after a subject or clinical study receives a drug or treatment regimen
3 secondary outcomes
Objective response rate
Time frame: up to 2 years
Disease control rate
Time frame: up to 2 years
Overall survival
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Camrelizumab combined with apatinib mesylate in people with Solid Tumor, run by Henan Cancer Hospital 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 10 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 19 May 2022. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2022.