A Trial of TQB2868 Plus Platinum-based Chemotherapy With or Without Bevacizumab in the First-line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer

NCT05998941 | Withdrawn Phase 2

• 1 other identifier: TQB2868-II-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

This study used a single-arm, open phase II multicenter trial design. All eligible subjects received TQB2868 plus platinum-based chemotherapy with or without bevacizumab. A total of 39 subjects will be enrolled.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Investigator-assessed objective response rate (ORR)

  The proportion of subjects who achieve a prespecified reduction in tumor volume and maintain the minimum time requirement, including complete response (CR) and partial response (PR).

  Baseline to CR or PR ,about 12 months

Secondary Outcomes (11)

• Progression free survival (PFS)

  Baseline up to PD or death, about 24 months

• Disease control rate (DCR)

  Baseline up to PD or death, about 24 months

• Duration of response (DOR)

  Baseline up to PD or death, about 24 months

• Overall survival (OS)

  Baseline up to die, about 36 months

• PFS rate (≥6 months)

  Baseline up to PD or death, about 24 months

Study Arms (1)

TQB2868 injection + Paclitaxel injection + Cisplatin/Carboplatin injection ± Bevacizumab injection

EXPERIMENTAL

TQB2868 injection + paclitaxel injection + cisplatin/carboplatin injection ± bevacizumab injection, 3 weeks (21 days) as a treatment cycle.

Drug: TQB2868 injection; Drug: Paclitaxel injection; Drug: Cisplatin injection; Drug: Carboplatin injection; Drug: Bevacizumab injection

Interventions

TQB2868 injection DRUG

TQB2868 injection is an anti-programmed cell death protein 1 (PD-1)/ transforming growth factor-β (TGF-β) dual-function fusion protein.

TQB2868 injection + Paclitaxel injection + Cisplatin/Carboplatin injection ± Bevacizumab injection

Paclitaxel injection DRUG

Paclitaxel injection prevents depolymerization of microtubules, inhibits mitosis, and hinders normal cell division.

TQB2868 injection + Paclitaxel injection + Cisplatin/Carboplatin injection ± Bevacizumab injection

Cisplatin injection DRUG

Cisplatin injection can inhibit the DNA replication process of cancer cells

TQB2868 injection + Paclitaxel injection + Cisplatin/Carboplatin injection ± Bevacizumab injection

Carboplatin injection DRUG

Carboplatin injection acts directly on DNA, thus inhibiting the vigorous division of tumor cells.

TQB2868 injection + Paclitaxel injection + Cisplatin/Carboplatin injection ± Bevacizumab injection

Bevacizumab injection DRUG

Bevacizumab is a humanized monoclonal antibody against vascular endothelial growth factor (VEGF).

TQB2868 injection + Paclitaxel injection + Cisplatin/Carboplatin injection ± Bevacizumab injection

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed persistent, recurrent or metastatic (International Federation of Gynecology and Obstetrics (FIGO) stage IVB) cervical cancer with squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma;
• It is not suitable for radical treatment such as surgery, radiotherapy and concurrent chemoradiotherapy;
• No previous systemic therapy for persistent, recurrent or metastatic cervical cancer;
• Provide archived or freshly obtained tumor tissue samples within the past 2 years or provide traceable test reports;
• years old ≤75 years old (calculated on the date of signing the informed consent); Eastern Cooperative Oncology Group (ECOG) score 0-1; Expected survival ≥3 months;
• At least one measurable lesion according to (Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria;
• The main organs function well and meet the following standards:
• Blood routine test criteria (in the case of no blood transfusion and no correction by hematopoietic stimulating factor drugs within 14 days before screening) : absolute neutrophil count (ANC) ≥1.5×109 /L; Platelet ≥100×109 /L; Hemoglobin ≥100 g/L.
• Blood biochemical tests should meet the following criteria: total bilirubin (TBIL) ≤2× upper limit of normal (ULN) (≤3×ULN in Gilbert syndrome patients); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN. If liver metastasis is present, ALT and AST≤5×ULN; Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥60 mL/min; Serum albumin (ALB) ≥30g/L.
• Urine routine examination criteria: urine routine indicated that urinary protein \<++; If urinary protein ≥++, it should be confirmed that 24-hour urinary protein quantification ≤1.0 g.
• Coagulation function test criteria: prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) ≤1.5×ULN (no anticoagulant therapy).
• Thyroid stimulating hormone (TSH) ≤ ULN; If abnormal, T3 and T4 levels should be examined. If T3 and T4 levels are normal, they can be selected.
• Echocardiographic assessment: left ventricular ejection fraction (LVEF) ≥50%.
• lead Electrocardiograph (ECG) assessment: Corrected QT interval prolongation (QTc)\<470ms (female).
• Female subjects of childbearing age should agree to use contraception (such as intrauterine device (IUD), birth control pill or condom) during the study period and within 6 months after the study. A negative serum or urine pregnancy test within 7 days prior to study entry and must be non-lactating.

You may not qualify if:

• Tumor disease and medical history:
• Have developed or are currently suffering from other malignant tumors within 3 years. The following two cases were included: other malignant tumors treated by single surgery, achieving R0 resection and no recurrence or metastasis; Cured non-melanoma skin cancer, nasopharyngeal carcinoma, and superficial bladder tumors
• Other pathological types, such as mucinous adenocarcinoma, clear cell adenocarcinoma, neuroendocrine tumor;
• tumor infiltration into the bladder or rectum;
• Subjects with known central nervous system (CNS) metastases and/or carcinomatous meningitis;
• Patients whose imaging showed that the tumor had invaded important blood vessels or the investigators judged that the tumor was highly likely to invade important blood vessels during the follow-up study and cause fatal hemorrhage;
• Uncontrollable pleural, pericardial, or peritoneal effusions requiring repeated drainage.
• Previous anti-tumor therapy:
• Received the last concurrent chemoradiotherapy for radical surgery or postoperative adjuvant therapy within 3 months before the first medication; Received palliative radiotherapy within 2 weeks before the first dose;
• Previously received platinum-based dual agents or any other chemotherapy agents in concurrent chemoradiotherapy for radical purposes;
• Received Chinese patent medicine with anti-tumor indications specified in the National Medicinal Products Administration (NMPA) approved drug instructions within 2 weeks before the first drug use;
• Prior treatment with anti-angiogenic therapy, immune checkpoint inhibitor therapy, or any treatment targeting immune costimulatory factors, which target the immune mechanism of tumor immune action;
• Patients who received immunoregulatory drugs within 2 weeks before the first dose;
• Non-resolved toxicity of grade 1 or higher than Common Terminology Criteria for Adverse Events (CTCAE) due to any previous treatment, excluding alopecia, peripheral sensory impairment.
• Comorbidities and medical history:

Sponsors & Collaborators

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

Study Sites (2)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400000, China

Location

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Paclitaxel; Cisplatin; Carboplatin; Bevacizumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

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

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 21, 2023
• Study Start: August 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: June 1, 2025
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

CN (2)