Paclitaxel and DDP Combined With Anlotinib in the First-line Treatment for Patients With Advanced Esophageal Squamous Cell Carcinoma（ESCC）.

NCT04063683 | Unknown Phase 2

• 1 other identifier: 2019315
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 6

Brief Summary

To evaluate the efficacy and safety of paclitaxel and DDP combined with Anlotinib in the treatment of advanced esophageal squamous cell carcinoma.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progress free survival (PFS)

  From first treatment，each 42 or 63 days until PD or death(up to 24 months)

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  each 42 or 63 days until intolerant the toxicity or PD (up to 24 months) ]

• Disease Control Rate (DCR)

  each 42 or 63 days until intolerant the toxicity or PD (up to 24 months) ]

• Duration of Response(DOR)

  each 42 or 63 days until intolerant the toxicity or PD (up to 24 months)

Study Arms (1)

Anlotinib with chemotherapy

EXPERIMENTAL

Drug: Anlotinib Hydrochloride, Paclitaxel, cisplatin

Interventions

Anlotinib Hydrochloride, Paclitaxel, cisplatin DRUG

* anlotinib: 1 capsule (10mg) once a day, d1-d14 per cycle, 3 weeks for a treatment cycle. * Paclitaxel: intravenously infused at 135mg/ m2, administered d1 per cycle, 3 weeks for a treatment cycle. * Cisplatin: administered after paclitaxel, intravenously infused at 60-75 mg/m2, divided into d1-d3 medications per cycle; 3 weeks for one treatment cycle.

Anlotinib with chemotherapy

Eligibility Criteria

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

You may qualify if:

• histopathology confirmed unresectable, locally recurrent or metastatic advanced esophageal squamous cell carcinoma (excluding mixed type adenosquamous carcinoma );
• 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);
• Age from 18-75 years old;
• ECOG PS score: 0-1; expected survival time more than 3 months;
• Main organs function is normal;
• Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 3 months after study is stopped；the result of serum or urine pregnancy test should be negative before enrollment；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 2 months after study is stopped.
• Patients should participate in the study voluntarily and sign informed consent

You may not qualify if:

• Patients tends to have complete obstruction or patients requiring interventional treatment for obstruction;
• ulcerated esophageal squamous cell carcinoma patients;
• after esophageal or endotracheal stent implantation;
• 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 ESCC who have not undergone surgical resection but have not reduced esophageal lesions after radiotherapy;
• allergic to 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);
• The of liver metastases accounts for more than 50% of the total liver volume;
• 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 CTC AE grade \>1, 4 weeks before of enrollment; other sites of bleeding NCI CTC AE 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.
• A history of gastrointestinal perforation and/or fistula occurred within 6 months prior to treatment; or an overactive/venous thrombosis event such as a cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and lung Embolism.
• Symptomatic central nervous system metastasis and/or cancerous meningitis are known to exist;

Sponsors & Collaborators

• Henan Cancer Hospital: lead
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (6)

ANYANG Cancer Hospital

Anyang, Henan, 455000, China

Location

First Affiliated Hospital of Henan University of Science and Technolog

Luoyan, Henan, China

Location

Henan cancer hospital

Zhengzhou, Henan, 450000, China

Location

Qilu Hospital

Jinan, Shandong, China

Location

Shandong Cancer Hospital

Jinan, Shandong, China

Location

Linyi Central Hospital

Linyi, Shandong, China

Location

Related Publications (1)

• Li N, Wu T, Hong YG, Guo YZ, Cheng YF, Ma YJ, Bie LY, Cui DH, Gao XH, Tan BX, Li BS, Luo SX, Wang JS. A multi-center, single-arm, phase II study of anlotinib plus paclitaxel and cisplatin as the first-line therapy of recurrent/advanced esophageal squamous cell carcinoma. BMC Med. 2022 Dec 8;20(1):472. doi: 10.1186/s12916-022-02649-x.

  PMID: 36482345 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Paclitaxel; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• LUO SUXIA

  Henan Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 21, 2019
• Study Start: October 7, 2019
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: August 24, 2021

Record last verified: 2021-08

Locations

CN (6)