Prospective clinical trial of anticancer vascular inhibitors combined with PD-1 monoclonal antibody in the treatment of metastatic and / or unresectable head and neck mucosal melanoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000036500

Enrollment

Unknown

Registered

2020-08-23

Start date

2020-10-01

Completion date

Unknown

Last updated

2020-09-14

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

Conditions

head and neck mucosal melanoma

Interventions

experimental group:PD-1 monoclonal antibody + anti tumor vascular inhibitor

control group:PD-1 monoclonal antibody

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Subjects must be pathologically diagnosed with a 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) The expected survival was more than 12 weeks; 6) The laboratory test values met the following requirements: absolute neutrophil count (ANC) >= 2.0 x 10^9 / L; platelet >= 100 x 10^9 / L (including liver cancer patients require >= 75 x 10^9 / L); hemoglobin >= 9 g / dL or >= 5.6 mmol / L. Serum creatinine = 50ml / min (Cockcroft Gault formula calculation method [Annex 3]). Serum albumin (ALT <= 2.5) and alanine aminotransferase (ALT <= 2.5) were collected before transfusion. International standard ratio (INR) or prothrombin time (PT) <= 1.5 x ULN; activated partial coagulation time (APTT) <= 1.5 x ULN. There was no significant abnormality in thyroid function (patients with hypothyroidism treated with hormone replacement therapy and stable disease should not be excluded). Women of childbearing age need to receive serum pregnancy test, and the patients must be negative for 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 is in danger; 4) Those who have mental illness and can not cooperate with treatment; 5) Other researchers consider that it is not suitable for treatment.

Design outcomes

Primary

Measure	Time frame
objective response rate;	—

Secondary

Measure	Time frame
Progression free survival;overall survival;	—

Countries

China

Contacts

Public ContactWei Guo

The 9th People's Hospital, Shanghai Jiaotong University School of Medicine

guoweicn@yahoo.com+86 13901685814

Outcome results

None listed

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