Clinical Trial to Evaluate the Safety and Effectiveness of TQB2618 Injection Combined Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma

NCT05834543 | Terminated Phase 1

• 1 other identifier: TQB2618-AK105-Ib-03
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 10

Brief Summary

To investigate the efficacy and safety of TQB2618 injection combined Penpulimab and chemotherapy in the first-line treatment of recurrent/metastatic esophageal squamous cell carcinoma compared with Penpulimab combined chemotherapy. The primary efficacy outcomes are progression free survival (PFS) and objective response rate (ORR).

Conditions

Advanced Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• PFS

  The time from the first administration of the drug to disease progression or death (whichever occurs first).

  Baseline up to two years.

• ORR

  According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and iRECIST, the proportion of subjects whose tumors are evaluated as complete response(CR) and partial response(PR) by subcenter imaging evaluation. It is recorded from the first use of the drug to disease progression or initiation of a new anticancer treatment.

  Baseline up to two years.

Secondary Outcomes (6)

• Overall survival (OS)

  Baseline up to death event, assessed up to 2 years.

• Disease Control Rate (DCR)

  Baseline to up to two years.

• Duration of Remission (DOR)

  Baseline to up to two years.

• Incidence of adverse events (AEs)

  Baseline to up to two years.

• Severity of adverse events (AEs)

  Baseline to up to two years.

Study Arms (3)

TQB2618 injection +Penpulimab injection+Chemotherapy

EXPERIMENTAL

Experimental group in Cohort 1. TQB2618 injection, Penpulimab injection, Paclitaxel, Cisplatin, 21 days as a treatment cycle. After 4\~6 cycles, TQB2618 injection combined Penpulimab injection, 21 days as a treatment cycle.

Drug: TQB2618 injection, Penpulimab injection, Paclitaxel, Cisplatin

Penpulimab injection+Chemotherapy

ACTIVE COMPARATOR

Active comparator group in Cohort 1. Penpulimab injection, Paclitaxel, Cisplatin, 21 days as a treatment cycle. After 4\~6 cycles, Penpulimab injection 21 days as a treatment cycle.

Drug: Penpulimab injection, Paclitaxel, Cisplatin

TQB2618 injection +Penpulimab +TQB3617capsules

EXPERIMENTAL

Cohort 2. TQB2618 injection, Penpulimab injection, 21 days as a treatment cycle. TQB3617 capsules are administered on Day 1 and Day 14, 21 days as a treatment cycle.

Drug: TQB2618 injection, Penpulimab injection, TQB3617capsules

Interventions

TQB2618 injection, Penpulimab injection, Paclitaxel, Cisplatin DRUG

TQB2618 injection：Anti-TIM-3 monoclonal antibody. Penpulimab injection：Humanized Monoclonal Antibody to Programmed Cell Death Protein 1 (PD-1). Paclitaxel and Cisplatin are chemotherapy.

TQB2618 injection +Penpulimab injection+Chemotherapy

Penpulimab injection, Paclitaxel, Cisplatin DRUG

Penpulimab injection：Humanized Monoclonal Antibody to Programmed Cell Death Protein 1 (PD-1). Paclitaxel and Cisplatin are chemotherapy.

Penpulimab injection+Chemotherapy

TQB2618 injection, Penpulimab injection, TQB3617capsules DRUG

TQB2618 injection：Anti-TIM-3 monoclonal antibody. Penpulimab injection：Humanized Monoclonal Antibody to Programmed Cell Death Protein 1 (PD-1).

TQB2618 injection +Penpulimab +TQB3617capsules

Eligibility Criteria

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

You may qualify if:

• Nonresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (excluding mixed adenosquamous cell carcinoma) confirmed by histopathology or cytology;
• For Cohort 1: Those who have not received systematic treatment, or have relapse at least 6 months after the (new) adjuvant treatment/radical radiotherapy and chemotherapy; For Cohort 2: received platinum-based chemotherapy and immuno checkpoint inhibitor (PD-1/PD-L1, etc.) treatment and failed, the best effect of front-line immunotherapy CR, PR, or SD lasted ≥ 24 weeks, and there was evidence of imaging progression;
• Age: 18-75 years old (calculated based on the date of signing the informed consent); Eastern Cooperative Oncology Group (ECOG) score: 0-1; The expected survival period is more than 3 months;
• At least one measurable lesion was confirmed according to RECIST 1.1 standard; Measurable lesions should not have received local treatment such as radiotherapy (lesions located in the area of previous radiotherapy treated can also be selected as target lesions if progression is confirmed);
• The main organs function well and meet the following standards:
• The blood routine examination should meet the following requirements: (no blood transfusion, no use of hematopoietic stimulator drugs for correction within 14 days before the examination)
• Hemoglobin content (HB) ≥ 90g/L;
• Absolute neutrophil count (ANC) ≥ 1.5 ×10\^9/L；
• Platelet count (PLT) ≥ 100 × 10\^9/L.
• Biochemical examination shall meet the following standards:
• Total serum bilirubin (TBIL) ≤ 1.5 times of the upper limit of normal value (ULN);
• Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2.5ULN; In case of liver metastasis, ALT and AST ≤ 5ULN;
• Serum creatinine (Cr) ≤ 1.5ULN or creatinine clearance rate (CCr) ≥ 60ml/min; (Cockcroft-Default formula);
• Coagulation function is sufficient, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN;
• Thyroid function examination shall meet the following standards: thyroid stimulating hormone (TSH) ≤ ULN; If abnormal, exam the level of T3 and T4, patients with abnormal T3 and T4 can be enrolled.

You may not qualify if:

• Known esophageal squamous cell carcinoma which tended to complete obstruction under endoscope and needed interventional treatment to relieve obstruction;
• Increased risk of bleeding or fistula caused by tumor significantly invading adjacent organs (aorta or trachea);
• After esophageal or tracheal stent implantation;
• For Cohort 1: Patients who have used paclitaxel in adjuvant chemotherapy and have relapse or metastasis within one year (note: those who have relapse or metastasis for more than one year can be included in the study); Patients who received cisplatin dose ≥ 300mg/m2 in the year before;
• The load of liver metastases accounts for more than 50% of the whole liver volume;
• For Cohort 1: Those who have received anti-PD-1 or anti-PD-L1/PD-L2, TIM-3, CTLA-4 drugs or other therapies that act on T-cell co-stimulation targets or checkpoints in the past; For Cohort 2: Patients who have previously received BET inhibitor treatment.
• Patients with any serious and/or uncontrollable diseases, including:
• Have any clinical cardiovascular symptoms or diseases with poor control, including but not limited to: patients with poor blood pressure control using antihypertensive drugs (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); New York Heart Association (NYHA) grade II or above heart failure; Unstable angina pectoris; Myocardial infarction occurred in the past one year; Patients with arrhythmia (QTc ≥ 450ms (male), QTc ≥ 470ms (female)), or patients with left ventricular ejection fraction (LVEF)\<50% according to cardiac color Doppler examination;
• Active or uncontrolled serious infection (≥ NCI CTC AE level 2 infection);
• Poor control of diabetes (Fasting Blood Glucose (FBG)\>10mmol/L);
• Urine routine test showed that urine protein ≥++, and confirmed that the 24-hour urine protein content was more than 1.0 g;
• Renal failure requiring hemodialysis or peritoneal dialysis;
• Those who have epilepsy and need treatment;
• Major surgery (craniotomy, thoracotomy or laparotomy) has been performed within 4 weeks before the first dose of the study or is expected to require major surgery during the study treatment.
• A history of gastrointestinal perforation and/or fistula within 6 months before treatment; Or have experienced arterial/venous thrombosis events, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (10)

Tongling People's Hospital

Tongling, Anhui, 244099, China

Location

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, 241000, China

Location

AnYang Tumor Hospital

Anyang, Henan, 455000, China

Location

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471003, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

Location

Zhumadian Central Hospital

Zhumadian, Henan, 463003, China

Location

Affiliated Hospital of Jining Medical College

Jining, Shandong, 272007, China

Location

Changzhi People's Hospital

Changzhi, Shanxi, 046000, China

Location

Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, 046000, China

Location

Jincheng General Hospital

Jincheng, Shanxi, 048000, China

Location

MeSH Terms

Interventions

penpulimab; Paclitaxel; Cisplatin

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: April 28, 2023
• Study Start: May 26, 2023
• Primary Completion: October 23, 2024
• Study Completion: March 3, 2025
• Last Updated: July 16, 2025

Record last verified: 2024-10

Locations

CN (10)