advanced and metastatic esophageal squamous cell carcinoma
Conditions
Interventions
polymeric micellar paclitaxel (pm-Pac) plus cisplatin combined with tislelizumab:polymeric micellar paclitaxel (pm-Pac) plus cisplatin combined with tislelizumab
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: a. Patients aged 18-75 years old; b. Patients with initially treated advanced esophageal squamous cell carcinoma confirmed by histopathology, or patients with metastases more than 12 months after radical surgery, and metastases can not be resected; c. The patient's ECOG score is ?2 points, and the expected survival time ?3 months; d, white blood cells ?3.5×109/L, neutrophils ?1.5×109/L, hemoglobin ?100g/L, platelets ?80×109/L, serum liver enzymes in patients without liver metastasis are not higher than 2.5 times the upper limit of normal value. The level of serum liver enzyme and serum bilirubin in patients with liver metastasis are not higher than 5 times of the upper limit of normal, and the level of serum bilirubin is not higher than 1.5 times of the upper limit of normal. Serum creatinine level is not higher than 1.5 times the upper limit of normal; e. Have at least one lesion that can be measured by CT or MRI; f.no history of other malignant tumors; g.Those who are fertile but willing to take contraceptive measures; h. Signed written informed consent.
Exclusion criteria
Exclusion criteria: a. there are contraindications to immunotherapy (including long-term hormone use, radiation pneumonia history, etc.); b. Received live vaccination within 28 days prior to treatment; c. have received radiotherapy and chemotherapy, targeted therapy and immunotherapy; d. active autoimmune diseases (such as vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.); e. active hepatitis B or C patients, HIV patients, active tuberculosis, etc.; f. active infections that require antimicrobial treatment (such as antibiotics, antiviral drugs, antifungal drugs); g. Known history of allogeneic organ transplantation and existing hematopoietic stem cell transplantation; h. patients with interstitial lung disease or previous history of interstitial pneumonia; i. have a history of psychotropic drug abuse and can not quit or have mental disorders; j.Previous or co-existing uncured malignancies, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and superficial bladder cancer; k.pregnant or lactating women; A fertile patient who is unwilling or unable to take effective contraceptive measures; l. The investigator determines other circumstances that may affect the conduct of clinical studies and the determination of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, OS;progression-free survival, PFS;security; | — |
Countries
China
Contacts
Public ContactCao Guochun
Jiangsu Cancer Hospital
Outcome results
None listed