TQB2450 Solution for Injection (TQB2450)+Paclitaxel+Cisplatin ± Anlotinib in the Treatment of Esophageal Cancer.

NCT05013697 | Unknown Phase 2

• 1 other identifier: TQB2450-II-13
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 5

Brief Summary

The regimen of paclitaxel+cisplatin+TQB2450 injection combined or not combined with anlotinib is the first-line treatment of advanced esophageal squamous cell carcinoma. Take PFS as the main evaluation index, the purpose is to evaluate its effectiveness and safety

Conditions

Esophageal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS， RECIST assessment)

  each 42 days（Initial treatment） or 63 days ( Maintenance treatment) up to Progressive Disease or Intolerable toxicity （Up to 24 months）

Secondary Outcomes (5)

• Progression-free survival (iPFS)

  each 42 days（Initial treatment） or 63 days ( Maintenance treatment) up to Progressive Disease or Intolerable toxicity （Up to 24 months）

• Objective response rate (ORR)

  each 42 days（Initial treatment） or 63 days ( Maintenance treatment) up to Progressive Disease or Intolerable toxicity （Up to 24 months）

• Disease control rate (DCR）

  each 42 days（Initial treatment） or 63 days ( Maintenance treatment) up to Progressive Disease or Intolerable toxicity （Up to 24 months）

• Duration of response (DOR)

  each 42 days（Initial treatment） or 63 days ( Maintenance treatment) up to Progressive Disease or Intolerable toxicity （Up to 24 months）

• Incidence of Treatment-related adverse Events

  Through study completion, an average of 3 weeks

Study Arms (2)

Experimental group 1

EXPERIMENTAL

Initial treatment: Paclitaxel + Cisplatin + TQB2450 injection+ Anlotinib (4-6 cycles). Maintenance treatment: TQB2450 injection+Anlotinib.

Drug: Paclitaxel + Cisplatin + TQB2450 injection+ Anlotinib

Experimental group 2

EXPERIMENTAL

Initial treatment: Paclitaxel + Cisplatin + TQB2450 injection (4-6 cycles). Maintenance treatment: TQB2450 injection.

Drug: Paclitaxel + Cisplatin + TQB2450 injection

Interventions

Paclitaxel + Cisplatin + TQB2450 injection+ Anlotinib DRUG

TQB2450 injection: 1200 mg, i.v.gtt , d1;Anlotinib 10mg, po.qd , d1-14；Paclitaxel 135mg/m2, i.v.gtt , d1; Cisplatin 60-75mg/m2, i.v.gtt , d1-d3; The above schemes are repeated every three weeks. After 4-6 cycles, the regimen is changed to Anlotinib (10mg, po.qd , d1-14)+TQB2450 injection（1200 mg, i.v.gtt , d1）. The regimen is repeated every 3 weeks until the disease progresses.

Experimental group 1

Paclitaxel + Cisplatin + TQB2450 injection DRUG

TQB2450 injection: 1200 mg, i.v.gtt , d1;Paclitaxel 135mg/m2, i.v.gtt , d1; Cisplatin 60-75mg/m2, i.v.gtt , d1-d3; The above schemes are repeated every three weeks. After 4-6 cycles, the regimen is changed to TQB2450 injection（1200 mg, i.v.gtt , d1）. The regimen is repeated every 3 weeks until the disease progresses.

Experimental group 2

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed squamous cell carcinoma of the esophagus, locally advanced, unresectable, recurrent or metastatic disease.
• 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);
• and 75 years old;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1；Life expectancy of at least 3 months.
• the main organ function to meet the following criteria:
• (1)Blood routine tests met the following requirements:
• a) haemoglobin(HB)≥90g/L ； b) absolute neutrophil count(NEUT)≥1.5×109/L ； c) platelet count(PLT)≥100×109/L；
• （2） Biochemical tests met the following requirements： total bilirubin(TBIL)≤ 1.5 times the upper limit of normal (ULN) .≤5 × ULN if with liver involvement； serum creatinine ≤1.5 × the ULN or creatinine clearance≥50mL/min。
• （3） Coagulation or thyroid function meet the following criteria: International Normalized Ratio (INR) ≤1.5 and Partial Thromboplastin Time (PT) or activated PTT (APTT) ≤1.5 × (ULN))."
• Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 3 months after the last dose of study
• The patient volunteers to participate in the study, signs a consent form, has good compliance, and obeys the follow-up, and is willing and able to follow the protocol during the study.

You may not qualify if:

• Patients tends to have complete obstruction or patients requiring interventional treatment for obstruction;
• 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 symptoms of hematemesis, hematochezia and daily bleeding ≥ 2.5 mL, or any bleeding event with Common Terminology Criteria for Adverse Events （CTCAE） level 3 within 3 months before screening;
• allergic to study drugs 、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);
• 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 CTCAE grade \>1, 4 weeks before of enrollment; other sites of bleeding NCI CTCAE 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;
• Clinically significant ascites, including any ascites that can be found on a physical examination, ascites that has been treated or currently in need of treatment, and only those with a small amount of ascites but no symptoms can be selected;
• A moderate amount of fluid in both sides of the chest, or a large amount of fluid in one side of the chest, or has caused respiratory dysfunction Patient to be drained;
• known to have active tuberculosis;

Sponsors & Collaborators

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

Study Sites (5)

AnYang Tumor Hospital

Anyang, Henan, 455000, China

Location

The People's Hospital Of AnYang City

Anyang, Henan, 455000, China

Location

First Affiliated Hospital of Henan University of Science and Technolog

Luoyang, Henan, 471000, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

Related Publications (9)

• Lu D, Ni Z, Liu X, Feng S, Dong X, Shi X, Zhai J, Mai S, Jiang J, Wang Z, Wu H, Cai K. Beyond T Cells: Understanding the Role of PD-1/PD-L1 in Tumor-Associated Macrophages. J Immunol Res. 2019 Nov 4;2019:1919082. doi: 10.1155/2019/1919082. eCollection 2019.

  PMID: 31781673 BACKGROUND

• Ramjiawan RR, Griffioen AW, Duda DG. Anti-angiogenesis for cancer revisited: Is there a role for combinations with immunotherapy? Angiogenesis. 2017 May;20(2):185-204. doi: 10.1007/s10456-017-9552-y. Epub 2017 Mar 30.

  PMID: 28361267 BACKGROUND

• [1]He Jie, Shao Kang. The epidemiology, diagnosis and treatment of esophageal cancer in China and future strategies[J]. Chinese Journal of Cancer, 2011, 21(07): 501-504.

  BACKGROUND

• Gandini S, Massi D, Mandala M. PD-L1 expression in cancer patients receiving anti PD-1/PD-L1 antibodies: A systematic review and meta-analysis. Crit Rev Oncol Hematol. 2016 Apr;100:88-98. doi: 10.1016/j.critrevonc.2016.02.001. Epub 2016 Feb 10.

  PMID: 26895815 RESULT

• Chen W, Sun K, Zheng R, Zeng H, Zhang S, Xia C, Yang Z, Li H, Zou X, He J. Cancer incidence and mortality in China, 2014. Chin J Cancer Res. 2018 Feb;30(1):1-12. doi: 10.21147/j.issn.1000-9604.2018.01.01.

  PMID: 29545714 RESULT

• Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

  PMID: 30207593 RESULT

• Guidelines Working Committee of Chinese Society of Clinical Oncology. Guidelines for Diagnosis and Treatment of Esophageal Cancer (2021 Edition) [M]. Beijing: People's Medical Publishing House, 2021.

  RESULT

• Blot, W. J. & Tarone, R. E. Esophageal cancer. Nat Rev Dis Prim. 3, 17048 (2017).

  RESULT

• Li N, Xia J, Gao X, Zhou J, Hong Y, Cui D, Zhao X, Wu T, Guo Y, Wang J, Luo S. First-line benmelstobart plus anlotinib and chemotherapy in advanced or metastatic/recurrent esophageal squamous cell carcinoma: a multi-center phase 2 study. Signal Transduct Target Ther. 2024 Nov 8;9(1):303. doi: 10.1038/s41392-024-02008-7.

  PMID: 39511164 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Paclitaxel; 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; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Suxia Luo, Doctor

  Henan Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Suxia Luo, Doctor

CONTACT

0371-65587697; 2290773710@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 19, 2021
• Study Start: September 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: July 31, 2023
• Last Updated: August 19, 2021

Record last verified: 2021-07

Locations

CN (5)