Recurrent and or metastatic head and neck squamous cell carcinoma
Conditions
Interventions
Case series:anlotinib 12mg once daily for 2 weeks ,then was stopped for 1 week,combined with sintilimab injection 200 mg the first day,every 21 days for a cycle, until disese progression or intolerabl
Sponsors
Chinese Academy of Medical Sciences Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. HNSCC confirmed pathologically (except nasopharyngeal carcinoma); 2. Recurrent and/or metastatic HNSCC not suitable for local treatment. Patients with only recurrent disease (no metastasis) must receive radiotherapy (as a postoperative adjuvant treatment or as a treatment for locally advanced HNSCC) as "local area treatment", and radiotherapy must be completed at least 6 months before screening imaging 3. Male or female, age >= 18 years; 4. ECOG performance status score 0-1; 5. According to the curative effect evaluation standard of solid tumors (RECIST version 1.1); 6. The patient has previously received platinum-based drug (cisplatin/carboplatin/nedaplatin)-based treatment and has a clear disease progression during the treatment (at least 2 cycles) or after the end of the treatment (refer to RECIST version 1.1), And the minimum dose of platinum drugs must meet: The minimum dose of cisplatin: the dose per cycle >= 60mg/m2, or the total dose within 8 weeks >= 120mg/m2; Minimum carboplatin dose: AUC>=4/cycle, or total AUC8 in 8 weeks. If the cisplatin is converted to carboplatin, the platinum dose can be calculated by the following formula: carboplatin 1 AUC = cisplatin 15mg/m2; The minimum dose of nedaplatin: the dose per cycle >= 80mg/m2, or the total dose within 8 weeks >= 160mg/m2; 7. Can provide tumor tissue samples for PD-L1 expression detection there is at least one measurable lesion; 8. The main organs function normally, that is, they meet the following standards: Routine blood test (no blood transfusion within 14 days before the screening test): neutrophils >=1.5 x 10^9/L, platelets >= 100 x 10^9/L, hemoglobin >= 90g/L; Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST), ALT and AST <= 3 ULN for those without liver metastasis, ALT and AST <= 5 ULN for those with liver metastasis; total bilirubin (TBIL) <= 1.5 ULN (Patients with Gilbert syndrome, <= 3 ULN); 9. The expected survival period exceeds 3 months; 10. Sign written informed consent voluntarily before screening.
Exclusion criteria
Exclusion criteria: 1. The patient has necrotic lesions, and the investigator judges that there is a risk of hemorrhage; 2. May have hypersensitivity to Anlotinib, Sintilimab or any excipients; 3. Have used PD1, PDL1, CTLA4 monoclonal antibodies and other immunomodulatory drugs or anti-angiogenesis drugs (such as Anlotinib, Apatinib, Bevacizumab, Endo, etc.); 4. The patient is using (or cannot be stopped within 1 week before the first administration of the study treatment) Chinese herbal medicine with anti-tumor indications; 5. Poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage; patients with indwelling catheters (such as PleurX? catheters) are allowed to participate; 6. At the beginning of the study treatment, there are still unhealed toxic reactions from the previous treatment, and the "Common Terminology Standards for Adverse Events (CTCAE 5.0) level exceeds level 1 (except for hair loss); 7. Spinal cord compression or symptomatic and untreated brain and spinal cord metastases (except those who are asymptomatic, stable, and do not need to use steroids for 4 weeks before the start of research treatment); 8. Poorly controlled tumor-related pain. For patients who need analgesics, they must receive a stable dose of treatment before participating in the study. Symptomatic lesions suitable for palliative radiotherapy (for example, bone metastases or metastases that cause nerve damage) should be treated before admission. Before enrollment, if appropriate, local-regional treatment should be considered for asymptomatic metastases that may cause functional defects or intractable pain (for example, epidural metastases that are not currently associated with spinal cord compression); 9. Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV antibody positive). Patients with positive hepatitis B antibodies are only eligible to participate in this study when HBV DNA>2000cps/ml. Patients with positive hepatitis C antibodies are only eligible to participate in this study if the polymerase chain reaction shows negative HCV RNA; 10. Patients suffering from other malignant tumors other than advanced head and neck squamous cell carcinoma within 5 years before randomization, with negligible risk of metastasis or death, and malignant tumors with curative results expected after treatment (for example, fully treated cervical carcinoma in situ, basal carcinoma) Except for squamous cell skin cancer, localized prostate cancer for radical treatment, and ductal carcinoma in situ for radical surgery; 11. In the 28 days before randomization, there are other major operations besides the diagnosis of advanced head and neck squamous cell carcinoma or major surgery is expected to be performed during the study period; 12. Patients who have undergone bone marrow transplantation or solid organ transplantation in the past; 13. Inoculate any live vaccines (for example, vaccines against infectious diseases, such as influenza vaccine, chickenpox vaccine, etc.) within 4 weeks (28 days) before randomization; 14. Any factors that affect the patient's oral medication, such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.; 15. Meet any of the following cardiac standards: In the resting state, the average corrected QT interval (QTc) obtained from the ECG examination > 470 msec (when the first abnormality occurs, repeat the measurement within 48 hours, and then 2 average result
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;DCR; | — |
Countries
China
Contacts
Public ContactGui Lin
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed