A Study of KC1036 Versus Investigator's Choice of Chemotherapy in Patients With Advanced Esophageal Cancer

NCT06194734 | Recruiting Phase 3

• 1 other identifier: KC1036-III-01
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of KC1036 versus investigator's choice of chemotherapy in patients with advanced recurrent or metastatic esophageal squamous cell carcinoma

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  OS is defined as the time from the start of randomization to death of any cause.

  Baseline to study completion (approximately 24 months)

Secondary Outcomes (6)

• Objective Response Rate (ORR)

  Baseline to study completion (approximately 24 months)

• Disease Control Rate (DCR)

  Baseline to study completion (approximately 24 months)

• Duration of Response (DOR)

  Baseline to study completion (approximately 24 months)

• Progression-free survival (PFS)

  Baseline to study completion (approximately 24 months)

• Incidence of Adverse events (AEs)

  Baseline to 30 days after the last dose of study treatment

Study Arms (2)

KC1036

EXPERIMENTAL

KC1036 will be administrated.

Drug: KC1036

Investigator's choice of chemotherapy

ACTIVE COMPARATOR

Irinotecan, Docetaxel or S-1 will be administrated.

Drug: Irinotecan; Drug: Docetaxel; Drug: S-1

Interventions

KC1036 DRUG

KC1036 60mg QD orally, before a meal, continuous administration, 21 days as a cycle

KC1036

Irinotecan DRUG

Irinotecan intravenously administered at 130-150 mg/m2 once every 2 weeks

Investigator's choice of chemotherapy

Docetaxel DRUG

Docetaxel intravenously administered at 60-75 mg/m2 once every 3 weeks；

Investigator's choice of chemotherapy

S-1 DRUG

S-1 orally administered 40-60mg Bid on Day 1 to Day 14 of every 3 weeks, 21 days as a cycle

Also known as: Tegafur-gimeracil-oteracil potassium

Investigator's choice of 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:

• Males or females aged 18 to 75 years;
• Histologically or cytologically confirmed esophageal or esophageal-gastric junction squamous cell carcinoma;
• Patient with advanced recurrent or metastatic esophageal squamous cell carcinoma previously treated with a PD-1 or PD-L1 inhibitor and at least second-line systemic therapy;
• At least one measurable tumor lesion according to RECIST 1.1;
• Eastern Cooperative Oncology Group performance status score of 0 or 1;
• Life expectancy \> 12 weeks;
• BMI≥16.0 and weight≥40 kg ;
• Adequate bone marrow, renal, and hepatic function;
• Female patients of childbearing potential with a negative blood pregnancy test completed within 7 days before randomization；
• Patients should participate in the study voluntarily and sign informed consent.

You may not qualify if:

• Any patient who is known to have untreated central nervous system (CNS) metastasis;
• Other kinds of malignancies within 5 years;
• Gastrointestinal abnormalities;
• Cardiovascular and cerebrovascular diseases;
• Prior therapies with vascular targeting inhibitor；
• Previously treated with Irinotecan, Docetaxel and Tegafur Gimeracil Oteracil Potassium；
• Involved in other clinical trials within 4 weeks before enrollment；Prior anti-tumor therapies with radiotherapy, immunotherapy, operation within 4 weeks before enrollment;Prior anti-tumor therapies with small molecule targeting drugs within 2weeks or 5 half-lives (whichever is longer) before enrollment; Prior anti-tumor therapies with chemotherapy within 3 weeks or 5 half-lives (whichever is longer) before enrollment;
• Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE 5.0 Grade 0 or 1;
• Uncontrolled massive ascites, pleural or pericardial effusion;
• Severe infection within 4 weeks prior to randomization (CTCAE \> Grade 2);
• Known history of human immunodeficiency virus (HIV) infection or current active hepatitis B or C infection;
• Pregnant or lactating women;
• Female subjects of child-bearing potential and male subjects of reproductive capacity who do not agree to use contraceptive measures during the study and for 6 months after the end of the study.
• Other patients are not eligible for enrollment assessed by investigators.

Sponsors & Collaborators

• Beijing Konruns Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Irinotecan; Docetaxel; S 1 (combination)

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)

Camptothecin; Alkaloids; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Jing Huang, Ph.D

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Huang, Ph.D

CONTACT

010-87788293; huangjingwg@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: February 5, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

CN (1)