A Multicenter Exploratory Study of Paclitaxel+Cisplatin+TQB2450 Injection Combined With or Without Anlotinib in the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma

Henan Cancer Hospital5 sites in 1 country48 target enrollmentSeptember 2021

ConditionsEsophageal Neoplasms

InterventionsPaclitaxel + Cisplatin + TQB2450 injection+ Anlotinib Paclitaxel + Cisplatin + TQB2450 injection

DrugsPaclitaxel + Cisplatin + TQB2450 injection+ Anlotinib Paclitaxel + Cisplatin + TQB2450 injection

Overview

Phase: Phase 2
Intervention: Paclitaxel + Cisplatin + TQB2450 injection+ Anlotinib
Conditions: Esophageal Neoplasms
Sponsor: Henan Cancer Hospital
Enrollment: 48
Locations: 5
Primary Endpoint: Progression free survival (PFS， RECIST assessment)
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The regimen of paclitaxel+cisplatin+TQB2450 injection combined or not combined with anlotinib is the first-line treatment of advanced esophageal squamous cell carcinoma. Take PFS as the main evaluation index, the purpose is to evaluate its effectiveness and safety

Registry

clinicaltrials.gov

Start Date

September 2021

End Date

July 31, 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Henan Cancer Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically confirmed squamous cell carcinoma of the esophagus, locally advanced, unresectable, recurrent or metastatic disease.
•Those who have not received systemic treatment before, or who relapsed after (new) adjuvant therapy/radical surgery more than 6 months ; Note: Including advanced or recurrent Patients who ever received only radiotherapy on non-target lesions. The duration from the end of palliative treatment for local lesions (non-target lesions) to enrollment should \> 2 weeks;
•According to RECIST 1.1, at least one measurable lesion; the measurable lesions should not have received local treatment such as radiotherapy (for the lesions in the area where received local radiotherapy, it can also be regarded as a target lesion if confirmed to progress according to the recist1.1);
•18 and 75 years old;
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1；Life expectancy of at least 3 months.
•the main organ function to meet the following criteria:
•(1)Blood routine tests met the following requirements:
•a) haemoglobin(HB)≥90g/L ； b) absolute neutrophil count(NEUT)≥1.5×109/L ； c) platelet count(PLT)≥100×109/L；
•（2） Biochemical tests met the following requirements： total bilirubin(TBIL)≤ 1.5 times the upper limit of normal (ULN) .≤5 × ULN if with liver involvement； serum creatinine ≤1.5 × the ULN or creatinine clearance≥50mL/min。
•（3） Coagulation or thyroid function meet the following criteria: International Normalized Ratio (INR) ≤1.5 and Partial Thromboplastin Time (PT) or activated PTT (APTT) ≤1.5 × (ULN))."

Exclusion Criteria

•Patients tends to have complete obstruction or patients requiring interventional treatment for obstruction;
•Patients with a high risk of bleeding or perforation due to the apparent invasion of adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed fistulas;
•Patients with symptoms of hematemesis, hematochezia and daily bleeding ≥ 2.5 mL, or any bleeding event with Common Terminology Criteria for Adverse Events （CTCAE） level 3 within 3 months before screening;
•allergic to study drugs 、paclitaxel and cisplatin preparations or excipients;
•Adjuvant chemotherapy patients who have used paclitaxel or cisplatin, and relapse or metastasize within one year
•A variety of factors affecting oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
•patients with any severe and / or uncontrolled disease, including:Unsatisfactory blood pressure control using antihypertensive drugs (systolic blood pressure ≥150 mmhg or diastolic blood pressure ≥100) Mmhg) patients; patients with grade ≥ myocardial ischemia or myocardial infarction, arrhythmia (including qt interval ≥ 480ms); according to nyha criteria, iii-iv cardiac dysfunction, or cardiac ultrasonography prompted left ventricular ejection fraction (lvef) \<50% of patients;live Severe infection that is sexual or uncontrolled;Liver diseases such as cirrhosis, decompensated liver disease, chronic active hepatitis;poor diabetes control (fasting blood glucose (fbg)\>10mmol/l);Urine routine indicates that urine protein ≥ ++, and confirmed 24-hour urine protein quantitation \> 1.0 g
•long-term unhealed wounds or fractures;
•Patients with active hemorrhage within 2 months of primary lesions; pulmonary hemorrhage with NCI CTCAE grade \>1, 4 weeks before of enrollment; other sites of bleeding NCI CTCAE grade \>2, 4 weeks before of enrollment; patients with bleeding tendency (such as active gastrointestinal ulcers) or patients undergoing thrombolytic or anticoagulant therapy such as warfarin, heparin or its analogues;
•Have undergone major surgery (craniotomy, thoracotomy or open surgery) within 4 weeks prior to the first dose study or Major surgery is required during the study period.

Arms & Interventions

Experimental group 1

Initial treatment: Paclitaxel + Cisplatin + TQB2450 injection+ Anlotinib (4-6 cycles). Maintenance treatment: TQB2450 injection+Anlotinib.

Intervention: Paclitaxel + Cisplatin + TQB2450 injection+ Anlotinib

Experimental group 2

Initial treatment: Paclitaxel + Cisplatin + TQB2450 injection (4-6 cycles). Maintenance treatment: TQB2450 injection.

Intervention: Paclitaxel + Cisplatin + TQB2450 injection

Outcomes

Primary Outcomes

Progression free survival (PFS， RECIST assessment)

Time Frame: each 42 days（Initial treatment） or 63 days ( Maintenance treatment) up to Progressive Disease or Intolerable toxicity （Up to 24 months）

Secondary Outcomes

Progression-free survival (iPFS)(each 42 days（Initial treatment） or 63 days ( Maintenance treatment) up to Progressive Disease or Intolerable toxicity （Up to 24 months）)
Objective response rate (ORR)(each 42 days（Initial treatment） or 63 days ( Maintenance treatment) up to Progressive Disease or Intolerable toxicity （Up to 24 months）)
Disease control rate (DCR）(each 42 days（Initial treatment） or 63 days ( Maintenance treatment) up to Progressive Disease or Intolerable toxicity （Up to 24 months）)
Duration of response (DOR)(each 42 days（Initial treatment） or 63 days ( Maintenance treatment) up to Progressive Disease or Intolerable toxicity （Up to 24 months）)
Incidence of Treatment-related adverse Events(Through study completion, an average of 3 weeks)