Mucosal MelanomaPhase 2NCT03986515
Apatinib Plus SHR1210 in Advanced Mucosal Melanoma
A Phase 2 study testing apatinib plus SHR-1210 in people with Mucosal Melanoma and Advanced Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
There is still no effective treatment for advanced mucosal melanoma at present. The efficacy of single-agent PD-1 inhibitors is less than 20%. It is urgent to explore regimens to improve the efficacy of PD-1 inhibitors in patients with advanced mucosal melanoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mucosal Melanoma, Advanced Cancer, Apatinib
- What is being tested?
- apatinib plus SHR-1210
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2019to 31 May 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
- mucosal melanoma by pathology
- expected lifespan ≥ 3 months
- ECOG 0-2
- failure after one kind of chemotherapeutic regimen
- at least one measurable lesion by RECIST 1.1
- enough organ function
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- blood pressure is normal; for patients with hypertension the blood pressure should be controlled in normal by antihypertensive drugs
- no other serious diseases conflicting with this regimen
- no history of other malignancies
- pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
- informed consent from the patient
Who cannot join
- Suffering from serious infectious diseases within 4 weeks before enrollment
- requiring intermittent use of bronchodilators or medical interventions
- usage of immunosuppressants before enrollment and the dose of immunosuppressant used ≥ 10mg / day oral prednisone for more than 2 weeks
- serious allergy
- serious mental diseases
- abnormal coagulation funtion,bleeding tendency or receiving thrombolytic or anticoagulant therapy
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- abdominal fistula, gastrointestinal perforation, or abdominal abscess within 4 weeks prior to enrollment
- previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe lung damage, etc.
- other situations evaluated by investigator unsuitable for this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Lingdi Zhao, Dr., +86-371-65587483, lingdizhao@126.com
About this study
Official title: Clinical Study of SHR-1210 Plus Apatinib in Patients With Advanced Mucosal Melanoma Whose Diseases Progress After Chemotherapy
There is still no effective treatment for advanced mucosal melanoma at present. The efficacy of single-agent PD-1 inhibitors is less than 20%. It is urgent to explore regimens to improve the efficacy of PD-1 inhibitors in patients with advanced mucosal melanoma. This study is performed to explore the safety and efficacy of apatinib plus SHR-1210 in patients with advanced mucosa melanoma whose diseases progress after chemotherapy.
Read the detailed description
Apatinib is an oral small molecule anti-angiogenesis inhibitors. It inhibits VEGFR-2 tyrosine kinase activity, thereby blocking VEGF-induced signaling and exerting a strong inhibitory effect on tumor angiogenesis.Apatinib has shown anti-melanoma activity in retrospective study. However, the efficacy is still very low. SHR-1210 is an anti-PD-1 antibody produced by Hengrui Pharmaceutical Co., Ltd. Apatinib plus SHR-1210 has shown synergy in several malignancies. This study is conducted to explore the efficacy and safety in advanced mucosa melanoma
- Conditions
- Mucosal Melanoma, Advanced Cancer, Apatinib, SHR-1210
- Being tested
- apatinib plus SHR-1210
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apatinib plus SHR-1210Drug
apatinib 250mg qd, 3-5 days later SHR-1210 200mg q3w
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | apatinib 250mg orally once a day until disease progression of occurrence of intolerable adverse events.
SHR-1210 200mg every two weeks until disease progression of occurrence of intolerable adverse events.
(the first dose of SHR-1210 is set on the 3-5 days after apatinib Receives: Drug: apatinib plus SHR-1210 |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
the proportion of patients with CR, PR, and SD in the group
Measured: three months
Secondary outcomes (2)
progression-free survival
the time frame from the first day of apatinib to the date of confirmed progressive disease or death which one occurrs first.
Measured: six months
overall survival
the time frame from the first day of apatinib to the date of death
Measured: eighteen months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start4 Jun 2019
- Primary completion31 May 2021 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mucosal MelanomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jing Ding, Master, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986515
- Sponsor's protocol ID
- HenanCH immunotherapy003
- Status last verified
- Jun 2019
- First submitted
- 11 Jun 2019
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang Y, Wang T, Lyu AQ, Zhang F, Li FH, Zhao LD, Wang ZB, Shang YM, Ma BZ, Dong XQ, Gao QL. Real-world study of SHR-1210 plus apatinib in the treatment of BRAF-negative mucosal melanoma: efficacy, safety and implications of precision medicine. Front Immunol. 2026 Apr 21;17:1755669. doi: 10.3389/fimmu.2026.1755669. eCollection 2026.
PubMed 42093981
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of SHR-1210 Plus Apatinib in Patients With Advanced Mucosal Melanoma Whose Diseases Progress After Chemotherapy
- ClinicalTrials.gov ID
- NCT03986515
- Acronym / sponsor ID
- HenanCH immunotherapy003
- Conditions
- Mucosal Melanoma, Advanced Cancer, Apatinib, SHR-1210
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 14 Jun 2019 (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.
There is still no effective treatment for advanced mucosal melanoma at present. The efficacy of single-agent PD-1 inhibitors is less than 20%. It is urgent to explore regimens to improve the efficacy of PD-1 inhibitors in patients with advanced mucosal melanoma. This study is performed to explore the safety and efficacy of apatinib plus SHR-1210 in patients with advanced mucosa melanoma whose diseases progress after chemotherapy.
Detailed description
Apatinib is an oral small molecule anti-angiogenesis inhibitors. It inhibits VEGFR-2 tyrosine kinase activity, thereby blocking VEGF-induced signaling and exerting a strong inhibitory effect on tumor angiogenesis.Apatinib has shown anti-melanoma activity in retrospective study. However, the efficacy is still very low. SHR-1210 is an anti-PD-1 antibody produced by Hengrui Pharmaceutical Co., Ltd. Apatinib plus SHR-1210 has shown synergy in several malignancies. This study is conducted to explore the efficacy and safety in advanced mucosa melanoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: apatinib plus SHR-1210apatinib 250mg orally once a day until disease progression of occurrence of intolerable adverse events. SHR-1210 200mg every two weeks until disease progression of occurrence of intolerable adverse events. (the first dose of SHR-1210 is set on the 3-5 days after apatinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- mucosal melanoma by pathology
- expected lifespan ≥ 3 months
- ECOG 0-2
- failure after one kind of chemotherapeutic regimen
- at least one measurable lesion by RECIST 1.1
Key exclusion criteria (9 listed)
- Suffering from serious infectious diseases within 4 weeks before enrollment
- requiring intermittent use of bronchodilators or medical interventions
- usage of immunosuppressants before enrollment and the dose of immunosuppressant used ≥ 10mg / day oral prednisone for more than 2 weeks
- serious allergy
- serious mental diseases
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 |
|---|---|---|
| apatinib plus SHR-1210apatinib 250mg qd, 3-5 days later SHR-1210 200mg q3w | Drug | treatment group |
Primary outcome
objective response rate
Time frame: three months
the proportion of patients with CR, PR, and SD in the group
2 secondary outcomes
progression-free survival
Time frame: six months
overall survival
Time frame: eighteen months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- Derived from this study: PubMed 42093981Zhang Y, Wang T, Lyu AQ, Zhang F, Li FH, Zhao LD, Wang ZB, Shang YM, Ma BZ, Dong XQ, Gao QL. Real-world study of SHR-1210 plus apatinib in the treatment of BRAF-negative mucosal melanoma: efficacy, safety and implications of precision medicine. Front Immunol. 2026 Apr 21;17:1755669. doi: 10.3389/fimmu.2026.1755669. eCollection 2026.
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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.
Jing Ding, Master principal investigator
Henan Cancer Hospital
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 apatinib plus SHR-1210 in people with Mucosal Melanoma and Advanced Cancer, 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 11 inclusion and 9 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 14 Jun 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lingdi Zhao, Dr. (+86-371-65587483, lingdizhao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: three 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 NCT03986515, which also lists 1 linked publication.
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 14 Jun 2019.