A Two Arm, Randomized, Prospective, Multicenter Study of Penpulimab Combined With Anlotinib Hydrochloride and Chemotherapy in the Perioperative Treatment of Locally Advanced Resectable Esophageal Cancer
Overview
- Phase
- Phase 2
- Intervention
- Penpulimab;Anlotinib;albumin paclitaxel;oxaliplatin;lobaplatin
- Conditions
- Esophageal Cancer
- Sponsor
- Xijing Hospital
- Enrollment
- 194
- Locations
- 1
- Primary Endpoint
- the Pathological complete response (PCR) rate
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This study is a two arm, randomized, prospective, multicenter study on the perioperative treatment of locally advanced resectable esophageal cancer with penpulimab combined with anlotinib hydrochloride and chemotherapy.
Detailed Description
The study was a two arm, randomized, prospective, multicenter study. The experimental group was treated with penpulimab combined with anlotinib hydrochloride plus albumin paclitaxel and oxaliplatin, and the control group was treated with penpulimab combined with anlotinib hydrochloride plus albumin paclitaxel and lobaplatin
Investigators
Eligibility Criteria
Inclusion Criteria
- •only those who meet all the following requirements can be enrolled in this trial:
- •age 18-75 years old, both male and female;
- •according to gastroscope / ultrasonic gastroscope biopsy, the pathology suggests esophageal cancer, and the clinical diagnosis is ct2n1-3m0 or ct3n0-3m0 or ct4n0-3m0, and the TNM stage is stage ii-iva;
- •patients with non cervical esophageal cancer;
- •have not received previous systemic and local treatment for esophageal cancer according to RECIST 1 1 criteria at least one measurable lesion was used for imaging evaluation of neoadjuvant therapy;
- •5.ecog PS: 0-1 point;
- •estimated survival ≥ 12 months;
- •the subject had no dysfunction of major organs, and the investigator assessed that the thyroid, lung, bone marrow, liver, kidney and heart functions were basically normal;
- •women of childbearing age must have taken reliable contraceptive measures or had a pregnancy test (serum or urine) within 7 days before enrollment, and the results are negative, and are willing to use appropriate methods of contraception during the test and - 8 weeks after the last administration of test drugs. For men, they must agree to use appropriate methods of contraception or have been surgically sterilized during the trial and 8 weeks after the last administration of the trial drug;
- •the subjects voluntarily joined the study, signed the informed consent, had good compliance, followed the planned schedule, actively cooperated with returning to the hospital for regular clinical follow-up and necessary treatment, and cooperated with regular blood and tissue sample acquisition.
Exclusion Criteria
- •5 years of other malignant tumors, except for cured cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor \[ta (non invasive tumor), tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\];
- •patients with ulcerative esophageal squamous cell carcinoma;
- •patients with esophageal fistula or tracheal fistula;
- •those who are sensitive to anlotinib, pembrolizumab, albumin paclitaxel or oxaliplatin and excipients;
- •have a history of immune deficiency, including HIV positive or suffering from other acquired or congenital immune deficiency diseases, or have a history of organ transplantation;
- •patients with any severe and / or uncontrolled disease, including:
- •Patients with unsatisfactory blood pressure control (systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mmHg); 2) Myocardial ischemia or myocardial infarction of grade I or above; 3) Arrhythmia (including QT interval ≥ 480 MS) and grade I cardiac insufficiency; 4) Diabetes mellitus with poor blood glucose control (fasting blood glucose (FBG) \>10mmol/l) or high-dose glucocorticoid treatment; 5) Active or uncontrolled severe infection; 6) Decompensated liver disease, active hepatitis B (HBV-DNA ≥ 104copies/ml or 2000iu/ml) or hepatitis C (hepatitis C antibody and HCV RNA positive) were all above the lower limit of the analysis method; 7) Hyperthyroidism and hypothyroidism; 8) Active tuberculosis.
- •unrelieved toxic reactions higher than CTCAE grade 1 due to any previous treatment, excluding hair loss;
- •esophageal cancer patients with active bleeding within 2 months of the primary lesion;
- •patients whose tumors have invaded the important blood vessels or are judged by the investigator to be very likely to invade the important blood vessels during the follow-up study and cause fatal massive hemorrhage;
Arms & Interventions
penpulimab combined with anlotinib hydrochloride plus albumin paclitaxel and oxaliplatin
penpulimab：200mg, intravenous infusion, 30-60 minutes per infusion, once every 3 weeks, administered on the first day of each cycle anlotinib hydrochloride：Body weight \<60kg, 8mg Po, body weight ≥ 60kg, 10mg Po, D 1-14, q3w Albumin paclitaxel: 260mg/m2, intravenous infusion, 30 minutes per infusion, once every 3 weeks, d 1 medication per week oxaliplatin：130mg/m2, i.v., administered after albumin paclitaxel, on day 1 of each week; Three weeks is a treatment cycle.
Intervention: Penpulimab;Anlotinib;albumin paclitaxel;oxaliplatin;lobaplatin
penpulimab combined with anlotinib hydrochloride plus albumin paclitaxel and lobaplatin
penpulimab：200mg, intravenous infusion, 30-60 minutes per infusion, once every 3 weeks, administered on the first day of each cycle anlotinib hydrochloride：Body weight \<60kg, 8mg Po, body weight ≥ 60kg, 10mg Po, D 1-14, q3w Albumin paclitaxel: 260mg/m2, intravenous infusion, 30 minutes per infusion, once every 3 weeks, d 1 medication per week lobaplatin：50mg/m2, i.v., administered after albumin paclitaxel, on day 1 of each week; Three weeks is a treatment cycle.
Intervention: Penpulimab;Anlotinib;albumin paclitaxel;oxaliplatin;lobaplatin
Outcomes
Primary Outcomes
the Pathological complete response (PCR) rate
Time Frame: 2years
Pathological complete response (PCR) rate
Secondary Outcomes
- the rate of R0 resection(2years)
- Disease free survival time(2years)
- 1-year OS rate(2years)