Efficacy and Safety of Cadonilimab Plus Anlotinib in Advanced STS That Failed the Previous First-line Standard Treatment

NCT05926700 | Recruiting Phase 2

• 1 other identifier: 2023-0454
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Objective to evaluate the efficacy and safety of candonilimab combined with anlotinib in the treatment of progressive or metastatic soft tissue sarcoma that failed previous first-line standard therapy.

Conditions

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• Progression-Free-Survival （PFS）

  Time from randomization to disease progression

  through study completion，an average of 1 year

Secondary Outcomes (6)

• Overall survival （OS）

  through study completion，an average of 1 year

• objective response rate (ORR)

  through study completion，an average of 1 year

• disease control rate （DCR)

  through study completion，an average of 1 year

• time-to-response (TTR)

  through study completion，an average of 1 year

• Duration of Response(DOR)

  through study completion，an average of 1 year

Study Arms (1)

intervention group

EXPERIMENTAL

The subject will be treated with Candonilimab + anlotinib every 21 days as a treatment cycle: Candonilimab 10mg/kg, D1 administration; Anlotinib 12mg/ day was taken orally for 2 weeks and stopped for a week. Until the subject has disease progression, intolerable toxicity, and the investigator's decision, the subject withdraws informed consent, death or other reasons specified in the protocol.

Drug: Candonilimab

Interventions

Candonilimab DRUG

The patients were treated with Candonilimab + anlotinib, with Cadonilimab 10mg/kg, D1 administration; Anlotinib 12mg/ day was orally administered for 2 weeks and stopped for a week, with 21 days as a course of treatment.

intervention group

Eligibility Criteria

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

You may qualify if:

• Male or female, aged ≥18 years .
• Voluntarily sign written informed consent.
• Advanced or unresectable soft tissue sarcomas confirmed by pathology mainly include liposarcoma, leiomyosarcoma, synovial sarcoma, undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, fibrosarcoma, pleomorphic rhabdomyosarcoma, acinar soft tissue sarcoma, clear cell sarcoma, angiosarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undifferentiated sarcoma, sarcoma after radiotherapy, etc.
• Patients who have used at least one chemotherapy regimen (including anthracyclines) in the past (except for acinar soft tissue sarcoma and clear cell sarcoma) and are evaluated as disease progression according to the efficacy evaluation criteria of solid tumors within 6 months.
• According to RECIST 1.1, there was at least one measurable tumor lesion.
• ECoG score 0 or 1.
• The expected survival was ≥ 3 months.
• The main organs function well:
• a) Hematology (no blood components and cell growth factors were used to support treatment within 7 days before starting the study treatment):
• i. The absolute value of neutrophils ANC ≥ 1.5 × 109/l (1500/mm3).
• Ii Platelet count ≥ 100 × 109/l (100000/mm3).
• III. hemoglobin ≥ 90 g/l.
• b) Kidney:
• i. Creatinine clearance \* (CrCl) calculated value ≥ 50 ml/min.
• \*The Cockcroft Gault formula will be used to calculate CrCl (Cockcroft Gault formula)

You may not qualify if:

• Participated in the treatment of experimental drugs or used experimental devices within 4 weeks before the first administration of candonilimab.
• Had other active malignancies within 3 years before enrollment. Except for locally curable malignant tumors (manifested as cured), such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, endometrial, cervical or breast cancer in situ.
• Another clinical study is enrolled at the same time, unless it is an observational (non interventional) clinical study or the follow-up period of an interventional study (defined as the time from the first medication to the last medication of the previous clinical study is more than 4 weeks or the five half lives of the study drug are more than 5, whichever is the longest).
• Active autoimmune diseases requiring systemic treatment within two years before the start of study treatment, or autoimmune diseases that may recur or are planned to be treated according to the judgment of the investigator; The following exceptions: skin diseases that do not need systematic treatment (such as vitiligo, alopecia, psoriasis or eczema); Hypothyroidism caused by autoimmune thyroiditis only requires a stable dose of hormone replacement therapy; Well controlled type I diabetes; Subjects whose asthma in childhood has been completely relieved and who do not need any intervention after adulthood; The investigator judged that the disease would not recur without external triggers.
• Inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea) with active or requiring clinical treatment.
• The subject required systemic treatment with corticosteroids (\>10mg daily prednisone equivalent) or other immunosuppressive drugs within 14 days after taking the study drug. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal gland replacement doses of \>10mg daily prednisone equivalent were allowed. Subjects were allowed to use topical, ocular, intra-articular, intranasal, and inhaled corticosteroids (with minimal systemic absorption). Physiological alternative doses of systemic corticosteroids are allowed, even if \>10 mg / day of prednisone equivalent. Short term use of corticosteroids is allowed to prevent (such as contrast allergy) or treat non autoimmune diseases (such as delayed type hypersensitivity caused by contact allergens).
• He has previously received immune checkpoint inhibitors (such as anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (such as antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.), immune cell therapy and other treatments targeting tumor immune mechanism.
• The best swelling evaluation result of patients who had received previous treatment with anlotinib was PD, or SD ≤ 12 weeks.
• History of a known positive test for human immunodeficiency virus or known acquired immune deficiency syndrome.
• Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
• Known presence or history of interstitial lung disease.
• Necrotic lesions were found within 4 weeks before the subjects were enrolled, and the investigator judged that there was a risk of major bleeding.
• Serious infections occurred within 4 weeks before the first administration, including but not limited to complications requiring hospitalization, sepsis or severe pneumonia.
• Known to have active pulmonary tuberculosis (TB). Subjects suspected of active TB should be examined by chest X-ray, sputum and excluded by clinical symptoms and signs.
• Untreated patients with chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA \> 1000iu/ml, and patients with active hepatitis C should be excluded. Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV dna\<1000iu/ml), and cured hepatitis C patients can be enrolled. For HCV AB positive subjects, they are eligible to participate in the study only if HCV RNA test results are negative.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

RECRUITING

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Ying Dong

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

Ying Dong

CONTACT

13666669105; dongying74@zju.edu.cn

Rui Bai

CONTACT

15858224043; whiterui411@zju.edu.cn

Study Design

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

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 3, 2023
• Study Start: February 28, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2025-12

Locations

CN (1)