esophageal squamous cell carcinoma
Conditions
Interventions
experimental group:Penpulimab+Anlotinib+nab-paclitaxel
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 75 years old, male or female; 2. Esophageal squamous cell carcinoma confirmed by histology; 3. Unresectable advanced recurrent or metastatic esophageal cancer; 4. The subject must not be suitable for radical treatment, such as radical radiotherapy and chemotherapy and/or surgery; 5. Not previously received systemic treatment; 6. KPS score = 70 points; 7. Measurable lesions meeting RECIST criteria 8. Expected survival period = 3 months; 9. The main organ functions are normal, and there are no serious blood, heart, lung, liver, kidney dysfunction and immunodeficiency diseases. Laboratory examinations meet the following requirements: (1) Blood routine examination, which must meet the requirements (no blood transfusion within 14 days): a.HGB=110g/L; b. WBC=4.0×109/L; NEUT=2.0×109/L c.PLT=100×109/L (2) Biochemical examination must meet the following standards: a. BIL = 1.5 times upper limit of normal (ULN); liver metastases = 2.5 upper limit of normal b. ALT and AST=2.5×ULN; liver metastasis, ALT and AST=5×ULN; c. Serum Cr=1.5×ULN or endogenous creatinine clearance =50ml/min (Cockcroft-Gault formula) d. Thyroid-stimulating hormone (TSH) = upper limit of normal (ULN); if abnormal, T3 and T4 levels should be investigated, and T3 and T4 levels can be selected if normal. (3) Fecal occult blood (-) (4) Normal urine routine, or urine protein < (++), or 24-hour urine protein < 1.0 g 10. Normal blood coagulation function, no active bleeding and thrombosis disease. a. International normalized ratio INR=1.5×ULN, b. Partial thromboplastin time APTT=1.5×ULN c. Prothrombin time PT=1.5ULN 11. Women of childbearing age must have a negative pregnancy test (serum or urine) within 14 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of anlotinib hydrochloride; for men, Should be surgically sterilized or agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of anlotinib hydrochloride. 12. Patients voluntarily join the study and sign the informed consent (ICF); 13. Those who are expected to have good compliance can follow up the curative effect and adverse reactions according to the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1. Those who have previously used targeted drugs/immunotherapy; 2. Those who are known to be allergic to anlotinib hydrochloride, Penpulimab or any ingredients; 3. Patients with symptoms of brain metastases or meningeal metastases or in need of treatment; 4. Imaging (CT or MRI) shows that the tumor has obviously invaded the adjacent organs (aorta or trachea) of the esophageal lesion, resulting in patients with a higher risk of bleeding and fistula; 5. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA = 500 IU/ml), hepatitis C (positive hepatitis C antibody, and HCV- RNA is higher than the detection limit of the analytical method) or co-infected with hepatitis B and C; 6. Previously used immunosuppressive drugs within 14 days before the first use of Penpulimab, excluding nasal spray and inhaled corticosteroids or systemic steroid hormones at physiological doses (that is, no more than 10 mg/day prednisolone or equivalent drug physiology doses of other corticosteroids); 7. Receive live attenuated vaccine within 4 weeks before the first dose or plan to receive it during the study; 8. Patients with hypertension who cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure = 140 mmHg / diastolic blood pressure = 90 mmHg); 9. Patients with grade = 2 coronary heart disease, arrhythmia (including QTc interval prolongation > 450 ms for men and > 470 ms for women) and cardiac insufficiency; 10. There are many factors that affect the absorption of oral drugs, such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction; 11. Urine routine prompts urine protein = (++), or 24-hour urine protein volume = 1.0g; 12. Abnormal coagulation function (INR>1.5×ULN, APTT>1.5×ULN), with bleeding tendency; 13. Patients at risk of gastrointestinal bleeding, including the following: (1) Active peptic ulcer lesions and fecal occult blood (++ ~ +++); (2) Those who have a history of melena and hematemesis within 3 months; (3) For fecal occult blood (+) or (+/-), it is necessary to re-examine the stool routine within 1 week, and those who are still (+) or (+/-) must undergo gastroscopy. Those who are considered by the treating physician to be at potential bleeding risk 14. Hemoptysis within 3 months before entering the study; 15. Long-term anticoagulant therapy with warfarin or heparin is required, or long-term antiplatelet therapy is required (aspirin = 300 mg/day or clopidogrel = 75 mg/day); 16. Severe infection occurred within 4 weeks before the first administration (such as: need for intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever >38.5°C during the screening period/before the first administration; 17. Major surgery, open biopsy or significant trauma within 28 days before enrollment; 18. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 19. Those who have thrombosis diseases or receive anticoagulant drugs; 20. Pregnant or breastfeeding women; patients with childbearing potential who are unwilling or unable to take effective contraceptive measures; 21. Other conditions considered inappropriate by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR;Disease Control Rate, DCR;Overall Survival, OS;safety; | — |
Countries
China
Contacts
Public ContactZhi-Wei Chang
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed