TQB3616 Capsules in the Treatment of Dedifferentiated Liposarcoma

NCT05496569 | Terminated Phase 2

• 1 other identifier: TQB3616-II-03（stage2）
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

Brief Summary

A clinical trial evaluating TQB3616 capsules versus placebo in the treatment of dedifferentiated liposarcoma. Divided into 2 stages, the second stage, a total of 118 subjects are planned to be enrolled.

Conditions

Dedifferentiated Liposarcoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) assessed by an independent review committee

  From randomization to the time of disease progression or death, whichever occurs first.

  18 to 24 months

Secondary Outcomes (7)

• Progression-free survival assessed by the investigator.

  14 to 24 months

• Overall survival

  20 to 30 months

• Duration of disease remission

  18 to 24 months

• Objective response rate

  24 months

• Disease control rate

  24 months

Study Arms (2)

TQB3616 capsules

EXPERIMENTAL

TQB3616 capsule (180mg, quaque die, oral), 4 weeks (28 days) as a treatment cycle.

Drug: TQB3616 capsule

TQB3616 placebo

PLACEBO COMPARATOR

TQB3616 placebo (0mg, quaque die, oral), 4 weeks (28 days) as a treatment cycle.

Drug: TQB3616 placebo

Interventions

TQB3616 capsule DRUG

TQB3616 capsule is a cyclin-dependent kinase 4/6 kinase inhibitor

TQB3616 capsules

TQB3616 placebo DRUG

Placebo

TQB3616 placebo

Eligibility Criteria

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

You may qualify if:

• Subjects shall voluntarily join the research, capable of giving written informed consent with good compliance;
• Age: 18-75 years old (calculated based on the time of signing the informed consent form); The Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-1 points; Body mass index (BMI)\>18.5 and body weight\>40kg; Expected survival time\>3 months;
• Patients with dedifferentiated liposarcoma who were diagnosed as unresectable or refused surgery after multidisciplinary consultation, and the pathological and imaging review results showed the presence of dedifferentiated liposarcoma component, and the subjects must also meet any of the following categories:
• Newly diagnosed dedifferentiated liposarcoma;
• Patients with residual disease after surgery;
• Local recurrence and metastatic dedifferentiated liposarcoma;
• Patients with disease progression confirmed by imaging results within nearly 6 months; Note: Difficult to resection by surgery: （R0：Complete tumor resection /R1：Residual tumor cells at the resection margin ）resection cannot be achieved by surgery according to the investigator's assessment: ①The tumor is huge or involves important organs; ②The tumor is located in an important vascular pathway; ③The tumor has multiple metastases, It is difficult to control by surgery; ④ Combination of serious medical diseases can cause fatal surgical risks; ⑤ Recurrence after multiple operations is not suitable for immediate surgery.
• Treatment-naive subjects: Subjects who have not received systemic drug therapy or have not relapsed within 6 months after postoperative adjuvant therapy.
• Treatment-experienced subjects: Subjects who have relapsed within 6 months after receiving first-line systemic drug therapy or postoperative adjuvant therapy.
• According to the Response Evaluation Criteria in Solid Tumors 1.1（RECIST 1.1） criteria, there is at least one measurable lesion. If the measurable lesion is located in the area of previous radiotherapy, it should be clearly defined as a progressive state;
• Subjects have recovered to ≤Grade 1 or baseline (according to Common Terminology Criteria for Adverse Events Version 5.0 \[CTCAE v 5.0\]), alopecia and peripheral Grade 2 all acute toxic effects of prior treatment or surgery prior to first dose except for neuropathy;
• Adequate major organ function meeting the following criteria:
• Routine blood tests criteria (no blood transfusion or correction with hematopoietic stimulating factor drugs within 7 days before the examination):
• Hemoglobin (HGB)≥90.0g/L;
• Absolute neutrophil value (ANC)≥1.5×109/L;

You may not qualify if:

• Tumor disease and medical history:
• Subjects with atypical lipomatous tumor/well-differentiated liposarcoma, myxoid/round cell liposarcoma, pleomorphic liposarcoma on pathology and imaging review;
• Have developed or currently suffers from other malignant tumors within past 3 years. The following two conditions were eligible for enrollment: Other malignancies treated with single surgery, achieving 5 consecutive years of disease-free survival (DFS); Cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor-infiltrating basement membrane)\]; Patients with other sources of carcinoma in situ and patients with previous malignancies who are currently in remission will be eligible to participate in the study if the investigator determines that the likelihood of recurrence is very low and will require sponsor approval prior to enrollment of these patients;
• Severe bone damage caused by tumor bone metastasis; including pathological fractures of weight-bearing bones (such as vertebrae, pelvis, femur, tibia, phalanges, calcaneus, etc.) and spinal cord compression that occurred within 6 months or that the investigators judged to be likely to occur in the near future;
• Imaging Computed Tomography or Magnetic Resonance Imaging (CT or MRI) shows the presence of tumor thrombus, brain metastasis or the number of lesions \> 10;
• Uncontrolled pleural effusion, pericardial effusion or ascites that still needs repeated drainage (judgment by the investigator).
• Previous anti-tumor or concomitant drug therapy:
• Received chemotherapy (including anthracyclines), radiotherapy, major surgery, biological therapy, cytokine immunotherapy, hormone therapy, clinical trial drug therapy, traditional Chinese medicine with anti-tumor indications or Chinese patent medicine, etc.
• Received major surgery, major surgical treatment, incisional biopsy, obvious traumatic injury within 4 weeks before the first treatment with the study drug, or has not been able to fully recover from the previous surgery as judged by the investigator, and has anti-tumor indications Chinese medicine or proprietary Chinese medicine, etc.;
• Previously received Abemaciclib or Palbociclib and any other CDK4/6 inhibitor treatment;
• The target drug (or anti- programmeddeath-1/ Programmed cell death 1 ligand 1 and other immune drugs) is not used for at least 5 half-lives (calculated from the end of the last treatment) from the time of first receiving the study drug to the last time. If it is a combination drug, calculated based on the drug with the longest half-life;
• After receiving the study drug for the first time subjects who have used drugs or traditional chinese medicines containing strong Cytochrome P450 3A4(CYP3A4) inhibitors or inducers (such as Carbamazepine, Phenobarbital, Pioglitazone, etc.) within the first 4 weeks and cannot be stopped during the treatment period;
• Comorbid diseases and medical history:
• Liver abnormalities:
• Decompensated cirrhosis (Child-Pugh liver function Grade B or C);

Sponsors & Collaborators

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

Study Sites (3)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Liposarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 11, 2022
• Study Start: August 8, 2022
• Primary Completion: June 15, 2024
• Study Completion: September 28, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-09

Locations

CN (3)