cancer of unknown primary
Conditions
Interventions
Tislelizumab+nab-paclitaxel + carboplatin :nab-paclitaxel 260mg/m2 intravenous infusion + carboplatin (AUC 5) +Tislelizumab 200mg, every 21 days for a cycle of 4 to 6 cycles, followed by maintenance t
Sponsors
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: ? Age between 18 and 75 years old (inclusive of boundary values). ? Histologically confirmed metastatic tissue as adenocarcinoma, squamous cell carcinoma, or poorly differentiated malignancy. ? Clear indication of carcinoma of unknown primary origin (CUP) (obligatory pathological assessment required, including immunohistochemistry (IHC), systematic pathological analysis, and exclusion of malignant melanoma, malignant lymphoma, sarcoma, and neuroendocrine tumors; comprehensive imaging examinations required (CT scans of thorax, abdomen and pelvis, optional PET-CT); gastroscopy and colonoscopy necessary; relevant physical examinations required (gynecological consultation for women, breast examination for women with adenocarcinoma, urogenital system examination for patients with primary lesions in the peritoneum, retroperitoneum, or inguinal region, and otorhinolaryngological examination for patients with squamous cell carcinoma)). ? No prior systemic treatment: including chemotherapy, targeted therapy, or immunotherapy. ? Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0-1. ? Expected survival period of more than 3 months. ? Laboratory test data requirements within 7 days prior to screening (including the 7th day): neutrophil count =1.5×10^9/L, platelet count =90×10^9/L, hemoglobin =90g/L (without transfusion or blood products, and without correction using G-CSF or other hematopoietic stimulants within 14 days); total bilirubin =1.5 times the upper limit of normal (ULN), ALT and AST =2.5× ULN (=5× ULN for patients with liver metastasis), BUN and creatinine =1×ULN or creatinine clearance rate =50ml/min (according to Cockcroft-Gault formula). ? Presence of measurable lesions (according to RECIST 1.1 criteria). ? Adequate surgical resection specimen or biopsy specimen available for genetic testing. ? Women of childbearing potential must have reliable contraception in place or have a negative pregnancy test (serum or urine) within 7 days before enrollment, and be willing to use appropriate contraception during the trial and for 8 weeks after the last dose of trial medication. Men must agree to use appropriate contraception during the trial and for 8 weeks after the last dose of trial medication or be surgically sterilized. ? Voluntary participation in this study and signing of informed consent. If the subject is unable to read and sign the informed consent due to lack of capacity, etc., a guardian must represent the consent process and sign the informed consent form. If the subject is illiterate and unable to read the informed consent, a witness must witness the consent process and sign the informed consent form.
Exclusion criteria
Exclusion criteria: ? Includes extragonadal germ cell syndrome, neuroendocrine cancer, adenocarcinoma confined to the axillary lymph nodes (in females), peritoneal carcinoma (in females), or squamous cell carcinoma limited to the cervical, supraclavicular, or inguinal lymph nodes. Patients suitable for therapeutic surgery or radiation therapy are also excluded. ? Patients who have previously received systemic treatment for carcinoma of unknown primary. ? Those who have received any investigational drugs or anti-tumor drugs within 4 weeks before enrollment. ? Isolated surgically resectable lesions, including: adenocarcinoma in women confined to axillary lymph node metastasis and amenable to surgical resection, women with isolated resectable peritoneal lesions, single-site metastasis that are surgically resectable. ? History of other malignancies within the past five years, with the exception of cured cervical cancer or basal cell carcinoma of the skin. ? Symptomatic brain or leptomeningeal metastases (unless the patient has previously undergone cranial treatment > 6 months prior, had negative imaging results within 4 weeks before entering the study, and had stable clinical symptoms related to the tumor at the time of study entry). ? Clinically significant active bleeding. ? Major organ failure or other serious illness, including clinically relevant coronary disease, cardiovascular disease, or myocardial infarction, congestive heart failure, unstable angina, significant pericardial effusion, or unstable arrhythmia occurring within 6 months before enrollment. ? Alcohol or drug addiction. ? Severe neurological or psychiatric history. ? Severe infection, active infection requiring antimicrobial treatment (e.g., needing antibacterial, antiviral, or antifungal drugs). ? Active disseminated intravascular coagulation. ? Clinically symptomatic effusions requiring symptomatic treatment, including pleural effusion, ascites, or pericardial effusion. ? Pregnant or breastfeeding women; women of childbearing potential not using adequate contraception. ? Other situations that the researcher judges may affect the conduct and outcome assessment of the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR(Objective Response Rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| DoR(Duration of remission);CBR(Clinical benefit rate);Time to response;PFS(progression free survival);OS(overall survival);Survival at 12 months; | — |
Countries
China
Contacts
Public ContactFANG YONG
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine,
Outcome results
None listed