TC Plus PD-1 Inhibitors Combined With Anlotinib for Advanced Advanced Esophageal Cancer

NCT04471480 | Unknown

• 1 other identifier: TCAC-ESCC-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

A Controlled Clinical Study of TC/PD-1 Inhibitors Combined With anlotinib as First-line Treatment for Advanced ESCC

Conditions

ESCC

Keywords

PD-1; anlotinib

Outcome Measures

Primary Outcomes (2)

• objective response rate(ORR)

  complete response(CR)+partial response(PR) according to RECIST 1.1

  approximately 18 months

• overall survival (OS)

  overall survival is defined as the time from randomization to death from any cause

  approximately 36 months

Secondary Outcomes (1)

• progression-free survival(PFS)

  approximately 36 months

Study Arms (3)

group A，TCCA

EXPERIMENTAL

paclitaxel for Injection 175 mg/m2,IV, d1/paclitaxel for Injection (Albumin Bound) 260mg/m2,IV, d1, q3w +carboplatin AUC 4-6,IV, d12,q3w +anlotinib 10mg, PO, d1-14, q3w +camrelizumab 200 mg, IV, d1, q3w, after the treatment for 4-6 cycles, camrelizumab plus anlotinib for maintenance therapy until PD or intolerable toxicity

Drug: TC/PD-1 inhibitor/anlotinib

group B，TCC

EXPERIMENTAL

paclitaxel for Injection 175 mg/m2,IV, d1/paclitaxel for Injection (Albumin Bound) 260mg/m2,IV, d1, q3w +carboplatin AUC 4-6,IV, d12,q3w +camrelizumab 200 mg, IV, d1, q3w, after the treatment for 4-6 cycles, camrelizumab for maintenance therapy until PD or intolerable toxicity

Drug: TC/PD-1 inhibitor/anlotinib

group C，TC

OTHER

paclitaxel for Injection 175 mg/m2,IV, d1/paclitaxel for Injection (Albumin Bound) 260mg/m2,IV, d1, q3w +carboplatin AUC 4-6,IV, d12,q3w

Drug: TC/PD-1 inhibitor/anlotinib

Interventions

TC/PD-1 inhibitor/anlotinib DRUG

chemotherapy and immunotherapy plus antiangiogenic therapy

Also known as: TC/PD-1 inhibitor

group A，TCCA; group B，TCC; group C，TC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients volunteered to participate in the study and signed the informed consent;
• Age 18-75, both male and female;
• Histologically or cytologically confirmed advanced or metastatic (stage IIIB, III C or IV) ESCC .
• At least one measurable lesion according to RECIST 1.1,which should not be treated locally, such as radiotherapy.
• ECOG PS 0-1- Page 3 of 5 \[DRAFT\] -
• Expected survival ≥ 3 months
• Patients who never received systemic therapy in the past, including radiotherapy ,chemotherapy, targeted therapy and immunotherapy , or patients who relapsed more than 6 months after adjuvant chemotherapy.
• The main organ functions accorded with the following criteria within 7 days before treatment:
• (1)Blood routine examination ( without blood transfusion in 14 days): hemoglobin (HB) ≥ 90 g/L; neutrophil absolute value (ANC) ≥ 1.5 \*109/L; platelet (PLT) ≥80 \*109/L.
• (2) Biochemical tests should meet the following criteria: 1) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); 2) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 \*ULN, if accompanied by liver metastasis, ALT and AST ≤ 5\* ULN; 3) serum creatinine (Cr) ≤ 1.5\* ULN or creatinine clearance rate (CCr) ≥ 60 ml/min;4) Serum albumin (≥35g/L). (3) Doppler echocardiography: left ventricular ejection fraction (LVEF) ≥the low limit of normal value (50%).
• Tissue samples should be provided for biomarker analysis (such as PD-L1 ) Patients who could not provide new tissues could provide 5-8 paraffin sections of 3-5 μm by archival preservation.

You may not qualify if:

• Severe allergic reactions to humanized antibodies or fusion proteins in the past
• known to have hypersensitivity to any component contained in Endostar or antibody preparations;
• Diagnosed of immunodeficiency or received systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days before the study, allowing physiological doses of glucocorticoids (≤10mg/day prednisone or equivalent);
• Patients with active, known or suspected autoimmune diseases. Patients with type I diabetes, hypothyroidism requiring hormone replacement therapy, skin disorders requiring no systemic treatment(such as vitiligo, psoriasis or alopecia). Patients who would not triggers can be included.
• Serious heart disease, include congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction, and severe valvular disease.
• Patients treated targeted drugs such as bevacizumab, sunitinib, sorafenib, imatinib, famitinib, regiffenil, apatinib and anlotinib
• Patients recieved systemic antineoplastic therapy, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or mitomycin C within 6 weeks before the grouping),recieved over-extended-field radiotherapy (EF-RT) within 4 weeks before the grouping or limited-field radiotherapy to evaluate the tumor lesions within 2 weeks before the grouping
• Positive hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus antibody (HCV Ab), indicating acute or chronic infection.
• Patients with active pulmonary tuberculosis (TB) infection judged by chest X-ray examination, sputum examination and clinical physical examination. Patients with active pulmonary tuberculosis infection in the previous year should be excluded even if they have been treated; Patients with active pulmonary tuberculosis infection more than a year ago should also be excluded unless the course and type of antituberculosis treatment previously were appropriate.
• Patients with brain metastases with symptoms or symptoms controlling less than 2 months

Sponsors & Collaborators

• Dong Wang: lead

Study Sites (1)

Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

Related Publications (1)

• Xu M, Pu Y, Jiang Y, Liu Y, Feng Y, Zhao X, Li M. Anlotinib plus camrelizumab and chemotherapy as first-line treatment in patients with advanced esophageal squamous cell carcinoma. Sci Rep. 2025 Jul 1;15(1):22275. doi: 10.1038/s41598-025-06625-2.

  PMID: 40595001 DERIVED

MeSH Terms

Interventions

anlotinib

Central Study Contacts

Dong Wang, PH.D

CONTACT

86-23-68757181; dongwang64@hotmail.com

Dong Wang, PH.D

CONTACT

13678428206; dongwang64@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Oncology

Study Record Dates

• First Submitted: July 12, 2020
• First Posted: July 15, 2020
• Study Start: September 1, 2020
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2023
• Last Updated: July 15, 2020

Record last verified: 2020-07

Locations

CN (1)