Prospective clinical study of anti-tumor vascular inhibitors combined with PD-1 antibody in the treatment of metastatic and / or unresectable head and neck mucosal melanoma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100043847

Enrollment

Unknown

Registered

2021-03-04

Start date

2021-03-01

Completion date

Unknown

Last updated

2021-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

oral mucosal melanoma

Interventions

experimental group:anti-tumor vascular inhibitors combined with PD-1 antibody

control group: PD-1 antibody

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) The subject must be pathologically diagnosed with head and neck mucosal melanoma with measurable unresectable and / or distant metastases. 2) The patient did not receive any immunotherapy (except vaccination), 3) Not less than 18 years old, 4) ECoG score was 0-1, 5) Expected survival >= 12 weeks. 6) The laboratory test values meet the following requirements: absolute neutrophil count (ANC) >= 2.0 x 10^9 / L; platelet count >= 100 x 10^9 / L (including liver cancer patients >= 75 x 10^9 / L); hemoglobin >= 9 g / dL or >= 5.6 mmol / L. Serum creatinine = 50ml / min (Cockcroft Gault formula [Annex 3]). Serum total bilirubin = 2.8 g / dl (albumin was not infused within 2 weeks before blood collection). International standard ratio (INR) or prothrombin time (PT) <= 1.5 x ULN; activated partial coagulation time (APTT) <= 1.5 x ULN. No obvious abnormality of thyroid function (patients with hypothyroidism and stable disease treated with hormone replacement therapy should not be excluded). Women of childbearing age need to receive serum pregnancy test, and the enrolled patients must have negative serum test.

Exclusion criteria

Exclusion criteria: 1) The patient did not agree to participate in the clinical trial and did not obtain the signed informed consent; 2) Pregnant and lactating women; 3) The function of important organs is damaged and life-threatening; 4) Those suffering from mental illness and unable to cooperate with treatment; 5) Other researchers consider it unsuitable for treatment.

Design outcomes

Primary

Measure	Time frame
ORR;	—

Countries

China

Contacts

Public ContactGuo Wei

Ninth People’s Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine

guoweicn@sjtu.edu.cn+86 13901685814

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026