Clinical trial · Interventional
Apatinib Plus SHR1210 in Advanced Mucosal Melanoma
Clinical Study of SHR-1210 Plus Apatinib in Patients With Advanced Mucosal Melanoma Whose Diseases Progress After Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Apatinib | — | UNRESOLVED | — |
| Mucosal Melanoma | Mucosal Melanoma | ONTOLOGY_EXACT | 0.98 |
| SHR-1210 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| apatinib plus SHR-1210 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment group
- description
- 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
- interventionNames
- Drug: apatinib plus SHR-1210
Primary outcomes (1)
- measure
- objective response rate
- timeFrame
- three months
- description
- the proportion of patients with CR, PR, and SD in the group
Secondary outcomes (2)
- measure
- progression-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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
References
Publications (1)
- DERIVEDZhang 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. PMID 42093981