Neoadjuvant Therapy of Anlotinib Combined With Toripalimab and Chemotherapy for Resectable Esophageal Carcinoma

NCT05996484 | Not Yet Recruiting Phase 2

• 1 other identifier: NFEC-2023-310
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to explore the effectiveness and safety of the combination of Anlotinib, Toripalimab, and albumin-bound paclitaxel with cisplatin for neoadjuvant therapy in resectable esophageal squamous cell carcinoma. The study aims to improve the pathological complete response rate (pCR), R0 resection rate, and disease-free survival (DFS) in patients undergoing esophageal cancer surgery. The findings of this study will provide guidance and new options for the treatment of locally advanced esophageal cancer patients.

Conditions

Esophageal Carcinoma; Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• Pathologic complete remission (PCR)

  Primary tumor or lymph node surgery specimen pathological examination without residual tumor cell

  Immediately after the surgery

Secondary Outcomes (7)

• R0 resection rate

  Immediately after the surgery

• Objective response rate (ORR)

  Up to 36 month

• Disease control rate (DCR)

  Up to 36 month

• Disease-free survival (DFS)

  3(5) years after last patient enrolled

• Overall survival (OS)

  Up to 36 month

Study Arms (1)

Neoadjuvant Anlotinib Combined With Toripalimab and Chemotherapy

EXPERIMENTAL

Toripalimab+ Anlotinib+Albumin-bound paclitaxel+Cisplatin

Drug: Toripalimab; Drug: Anlotinib hydrochloride; Drug: Albumin paclitaxel; Drug: Cisplatin

Interventions

Toripalimab DRUG

Toripalimab, 240mg, IV., D1, every 3 weeks, 4 cycles.

Also known as: JS001

Neoadjuvant Anlotinib Combined With Toripalimab and Chemotherapy

Anlotinib hydrochloride DRUG

Anlotinib Hydrochloride is a capsule in the form of 8 mg ,10 mg and 12 mg, orally, once daily, 2 weeks on/1 week off, every 3 weeks, 4 cycles.

Also known as: Anlotinib

Neoadjuvant Anlotinib Combined With Toripalimab and Chemotherapy

Albumin paclitaxel DRUG

Albumin paclitaxel, 200-260 mg/m2, IV., D1, every 3 weeks, 4 cycles.

Also known as: Paclitaxel For Injection (Albumin Bound)

Neoadjuvant Anlotinib Combined With Toripalimab and Chemotherapy

Cisplatin DRUG

Cisplatin, 60-75 mg/m2, IV., D1, every 3 weeks, 4 cycles.

Also known as: CDDP

Neoadjuvant Anlotinib Combined With Toripalimab and 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:

• Age range: 18-70 years, both male and female.
• Patients with histopathological diagnosis of esophageal squamous cell carcinoma confirmed by gastroscopy/ultrasound gastroscopy, and clinical diagnosis of cT2N1-2M0 or cT3N0-2M0, with TNM staging of stage II-III B.
• Non-cervical esophageal cancer patients.
• No prior systemic or local treatment for esophageal cancer, with at least one measurable lesion for imaging evaluation of neoadjuvant therapy according to RECIST 1.1 criteria.
• ECOG PS (Eastern Cooperative Oncology Group Performance Status): 0-1.
• Estimated survival period ≥12 months.
• Subjects without significant dysfunction of major organs, with normal assessment of thyroid, lung, liver, kidney, and cardiac function.
• Reproductive-age women must have taken reliable contraceptive measures or undergone pregnancy testing (serum or urine) within 7 days prior to enrollment, with negative results, and be willing to use appropriate contraception during the trial and for 8 weeks after the last administration of the investigational drug. For males, they must agree to use appropriate contraception during the trial and for 8 weeks after the last administration of the investigational drug, or have undergone surgical sterilization.
• Subjects voluntarily participate in this study, sign an informed consent form, demonstrate good compliance, adhere to the planned schedule for regular clinical follow-up and necessary treatment, and cooperate in obtaining regular blood and tissue samples.

You may not qualify if:

• Patients who have had or currently have other malignant tumors within the past 1.5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invades lamina propria)\].
• Patients with ulcerative esophageal squamous cell carcinoma.
• Patients with esophageal fistula or tracheal fistula.
• Patients allergic to anlotinib, toripalimab, or albumin-bound paclitaxel.
• Patients with a history of immunodeficiency diseases, including HIV-positive patients or those with other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
• Patients with severe and/or uncontrolled diseases are excluded from the study, including:
• Patients with unsatisfactory blood pressure control (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mmHg).
• Patients with grade I or higher myocardial ischemia or myocardial infarction.
• Patients with arrhythmia (including QT interval ≥480 ms) and grade I heart failure.
• Patients with poorly controlled diabetes (fasting blood glucose \>10 mmol/L) or receiving high-dose glucocorticoid therapy.
• Patients with active or uncontrolled severe infections. 6.6 Patients with decompensated liver disease, active hepatitis B (HBV-DNA ≥10\^4 copies/ml or 2000 IU/ml), or hepatitis C (positive for hepatitis C antibodies and HCV RNA) exceeding the lower limit of the analytical method.
• Patients with hyperthyroidism or hypothyroidism. 6.8 Patients with active tuberculosis.
• Unresolved toxicities of grade 2 or higher, excluding alopecia, caused by any prior treatment.
• Individuals with multiple factors that affect oral medication administration, such as dysphagia, chronic diarrhea, and intestinal obstruction.
• Individuals with urine routine showing urinary protein ≥++, and confirmed 24-hour urine protein quantification \>1.0 g.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

toripalimab; anlotinib; Paclitaxel; Injections; Cisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; 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; Drug Administration Routes; Drug Therapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• kaican cai, M.D., PhD

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

di lu, M.D., PhD

CONTACT

13268379321; david_lu1989@163.com

Study Design

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

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 18, 2023
• Study Start: September 1, 2023
• Primary Completion: November 1, 2024
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share