Adriamycin and Ifosfamide Combined With Sintilimab

NCT04589754 | Recruiting Phase 2

• 1 other identifier: Sintilimab plus chemotherapy
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to explore the efficacy and safety of adriamycin and ifosfamide combined with sintilimab versus chemotherapy in the treatment of advanced or unresectable soft tissue sarcoma.

Conditions

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• Overall response rate, ORR

  The percentage of patients with complete remission and partial remission in patients with evaluable curative effect.

  up to 24 months

Secondary Outcomes (3)

• Progression-free survival, PFS

  From the beginning of observation to the end of observation（1 year) of the last enrolled patient

• Disease-free surviva, DFS

  From the beginning of observation to the end of observation (1 year) of the last enrolled patient

• Overall survival, OS

  From the beginning of observation to the end of observation (1 year) of the last enrolled patient

Study Arms (2)

Sintilimab plus chemotherapy

EXPERIMENTAL

Adriamycin and ifosfamide combined with sintilimab in the treatment of advanced or unresectable soft tissue sarcoma

Drug: Sintilimab plus chemotherapy; Drug: Adriamycin-based chemotherapy

Adriamycin-based chemotherapy

PLACEBO COMPARATOR

Adriamycin-based chemotherapy in the treatment of advanced or unresectable soft tissue sarcoma

Drug: Sintilimab plus chemotherapy; Drug: Adriamycin-based chemotherapy

Interventions

Sintilimab plus chemotherapy DRUG

AI regimen chemotherapy (ADM 50 mg / m2, D1 + IFO 2.5 g / m2, D1-3, IV drip) was used for 3 weeks; CAV / IE regimen alternate chemotherapy (regimen 1: CTX 1.2mg/m2 D1 + ADM 50mg / m2 D1 + VCR 1.4mg/m2 D1 and regimen 2: IFO 1.5g/m2 D1-5 + VP-16 100mg / m2 D1-5, IV drip). Regimen 1 and 2 were performed alternately, with a cycle of 3 weeks; sintilimab (10ml; 100mg) was administered intravenously every 3 weeks.

Adriamycin-based chemotherapy; Sintilimab plus chemotherapy

Adriamycin-based chemotherapy DRUG

AI regimen chemotherapy (ADM 50 mg / m2, D1 + IFO 2.5 g / m2, D1-3, IV drip) was used for 3 weeks; CAV / IE regimen alternate chemotherapy (regimen 1: CTX 1.2mg/m2 D1 + ADM 50mg / m2 D1 + VCR 1.4mg/m2 D1 and regimen 2: IFO 1.5g/m2 D1-5 + VP-16 100mg / m2 D1-5, IV drip). Regimen 1 and 2 were performed alternately, with a cycle of 3 weeks.

Adriamycin-based chemotherapy; Sintilimab plus chemotherapy

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients voluntarily participated in the study and signed informed consent;
• All advanced or non resectable soft tissue sarcomas confirmed by pathology failed or did not have standard treatment or could not tolerate standard treatment, Have at least one according to RECIST 1.1 the standard measurable lesions mainly included synovial sarcoma, leiomyosarcoma, alveolar soft tissue sarcoma, undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, liposarcoma, fibrosarcoma, clear cell sarcoma, angiosarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undifferentiated sarcoma, dermatofibrosarcoma protuberans, inflammatory myofibroblastic sarcoma Malignant solitary fibroma, sarcoma after radiotherapy. However, there are no standard treatment types, such as alveolar soft tissue sarcoma, post radiotherapy sarcoma, highly differentiated / dedifferentiated / pleomorphic liposarcoma, clear cell sarcoma, etc.; except for the following types: chondrosarcoma, osteosarcoma, malignant mesothelioma, gastrointestinal stromal tumor, etc;
• Advanced patients with unresectable lesions or lymph nodes or distant metastasis assessed by imaging;
• In the past three months, there was at least one measurable target lesion according to RECIST version 1.1 standard, and it can be accurately measured by magnetic resonance imaging (MRI) or computer tomography (CT) in at least one direction (the maximum diameter needs to be recorded), with conventional CT ≥ 20 mm or spiral CT ≥ 10 mm.
• They were 14-70 years old; ECoG PS score: 0-1; the expected survival time was more than 3 months;
• Within 7 days before treatment, the main organ functions met the following criteria:
• (1) Blood routine examination standard (without blood transfusion within 14 days)
• ① Hemoglobin (HB) ≥ 90g / L;
• ② The absolute value of neutrophil (ANC) ≥ 1.5 × 109 / L;
• Platelet (PLT) ≥ 80 × 109 / L.
• (2) Biochemical examination should meet the following standards:
• ① Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN);
• ② Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5uln, such as
• With liver metastasis, ALT and AST ≤ 5uln;
• ③ Serum creatinine (CR) ≤ 1.5uln or creatinine clearance rate (CCR) ≥ 60ml / min;

You may not qualify if:

• \) Patients who had previously received anti-PD-1 / PD-L1 antibody therapy.
• \) Other malignancies occurred or were present within 5 years, except for cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor \[ta (non invasive tumor), tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\];
• \) The patients with thyroid dysfunction after the best drug treatment;
• \) Systemic anti-tumor therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or mitomycin C within 6 weeks prior to the trial drug treatment) was planned within 4 weeks before enrollment or during the study period. Over extended field radiotherapy (ef-rt) was performed within 4 weeks before admission or limited field radiotherapy (rfrt) was performed within 2 weeks before grouping;
• \) With pleural effusion or ascites, it causes respiratory syndrome (≥ CTC AE grade 2 dyspnea \[grade 2 dyspnea refers to shortness of breath with a small amount of activity; it affects instrumental activities of daily living\]);
• \) Any unrelieved toxic reaction higher than CTC AE (4.01) grade 1 or above caused by previous treatment, excluding alopecia;
• \) Patients with any severe and / or uncontrolled disease, including:
• Patients with poor blood pressure control (SBP ≥ 150 mmHg, DBP ≥ 100 mmHg);
• Patients with myocardial ischemia or myocardial infarction of grade I or above, arrhythmia (including QTc ≥ 480ms) and congestive heart failure (NYHA) grade ≥ 2;
• Active or uncontrolled severe infection (≥ CTC AE Level 2 infection);
• Chronic liver disease, decompensated liver disease or decompensated hepatitis;
• Renal failure needs hemodialysis or peritoneal dialysis;
• Poor control of diabetes mellitus (FBG \> 10mmol / L);
• Urine routine examination showed that urine protein was ≥ + +, and 24-hour urine protein was more than 1.0 G;
• Patients with epilepsy and need treatment;

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Xing Zhang

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

sintilimab; Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Xing Zhang

  Sun Yat-sen University CancerCenter

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xing Zhang

CONTACT

020-87343383; zhangxing@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department of medical sarcoma and melanoma,Principal Investigator,Clinical Professor

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 19, 2020
• Study Start: July 26, 2021
• Primary Completion: December 30, 2025
• Study Completion (Estimated): July 30, 2026
• Last Updated: January 2, 2024

Record last verified: 2023-12

Locations

CN (1)