Clinical trial · Interventional
TQB2450 Solution for Injection (TQB2450)+Paclitaxel+Cisplatin ± Anlotinib in the Treatment of Esophageal Cancer.
A Multicenter Exploratory Study of Paclitaxel+Cisplatin+TQB2450 Injection Combined With or Without Anlotinib in the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma
NCT05013697CI-TRIAL-00053400unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel + Cisplatin + TQB2450 injection | Drug | — | UNRESOLVED |
| Paclitaxel + Cisplatin + TQB2450 injection+ Anlotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group 1
- description
- Initial treatment: Paclitaxel + Cisplatin + TQB2450 injection+ Anlotinib (4-6 cycles). Maintenance treatment: TQB2450 injection+Anlotinib.
- interventionNames
- Drug: Paclitaxel + Cisplatin + TQB2450 injection+ Anlotinib
- type
- EXPERIMENTAL
- label
- Experimental group 2
- description
- Initial treatment: Paclitaxel + Cisplatin + TQB2450 injection (4-6 cycles). Maintenance treatment: TQB2450 injection.
- interventionNames
- Drug: Paclitaxel + Cisplatin + TQB2450 injection
Primary outcomes (1)
- measure
- Progression free survival (PFS, RECIST assessment)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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); * 18 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. Exclusion Criteria: * 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; * suffering from interstitial lung disease requiring steroid therapy; * Uncontrolled metabolic disorders or other non-malignant tumors or systemic diseases or cancer secondary reactions that can lead to higher medical risks and/or survival Evaluation of uncertainty; * Significantly malnourished patients; * those who have a history of psychotropic substance abuse and are unable to quit or have a mental disorder; * A history of immunodeficiency, including a positive HIV test or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; * History of other primary malignancies, but the following : 1) complete remission of malignant tumors for at least 2 years prior to enrollment and no additional treatment during the study; 2) non-melanoma skin cancer or malignant freckle-like sputum with adequate treatment and no evidence of disease recurrence; 3) adequately treated and In situ carcinoma without evidence of disease recurrence; * Female patients who are pregnant or breastfeeding; * According to the judgment of the investigator, there is a concomitant disease that seriously endangers the safety of the patient or affects the completion of the study.
References
Publications (9)
- BACKGROUNDLu 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
- BACKGROUNDRamjiawan 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.
- RESULTGandini 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
- RESULTChen 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
- RESULTBray 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
- RESULTGuidelines 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.
- RESULTBlot, W. J. & Tarone, R. E. Esophageal cancer. Nat Rev Dis Prim. 3, 17048 (2017).