Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Sintilimab will be administered intravenously, a fixed dose of 200 mg. Paclitaxel 135mg/m2, carboplatin AUC=5. Once every 3 weeks.

Sintilimab plus Chemotherapy

The purpose of this study is to observe and evaluate the efficacy and safety of A sintilimab plus chemotherapy followed by definitive concurrent chemoradiotherapy in locally advanced esophageal squamous cell carcinoma.

Sintilimab Plus Chemotherapy Followed by dCRT in Locally Advanced ESCC

A Pilot Study of Sintilimab Plus Chemotherapy Followed by Definitive Concurrent Chemoradiotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma

Fudan University

Professor

Sarcoma

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Anti-Infective Agents

Etoposide

Ifosfamide

Etoposide phosphate

Isophosphamide mustard

Doxorubicin

Liposomal doxorubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

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

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

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.

Sintilimab plus chemotherapy

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

Xing Zhang

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.

At present, there are a number of clinical trials of chemotherapy drugs combined with anti PD-1 antibody in the treatment of cancer, but the clinical research of chemotherapy containing adriamycin combined with anti-PD-1 antibody for advanced STS patients is almost blank. Regimen containing adriamycin is the standard chemotherapy regimen for advanced STS approved by international guidelines. As an innovative PD-1 monoclonal antibody, more phase II clinical studies are needed to evaluate the efficacy and safety of sintilimab in a variety of cancers. For patients who fail or cannot tolerate first-line treatment, treatment options are still limited. In view of the above problems, this study aims to observe and explore the efficacy and safety of chemotherapy including adriamycin combined with sintilimab versus chemotherapy in the second-line treatment of patients with advanced STS, so as to provide more and better treatment options for patients with advanced STS.

Adriamycin and Ifosfamide Combined With Sintilimab

An Open, Multi-center, Randomized, Phase II Study of Adriamycin and Ifosfamide Combined With Sintilimab in the Treatment of Advanced or Unresectable Soft Tissue Sarcoma

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

PFS was defined as the time from randomization to objective tumor progression or death.

DFS is defined as the time from randomization to recurrence of tumor or death.

OS is defined as the time from randomization to death.

Sun Yat-sen University

Director of department of medical sarcoma and melanoma,Principal Investigator,Clinical Professor

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Neoplasm, Residual

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Gemcitabine

Pemetrexed

Cisplatin

Immunomodulating Agents

Participants received two to three cycles of neoadjuvant chemoimmunotherapy before surgery. Adjuvant chemotherapy was also administered for 2-3 cycles after surgery. In addition, MRD was detected within 30 days before surgery, 1 week after surgery, 1 month ±7days after surgery, 6 months after surgery.

Sintilimab: 200 mg via intravenous infusion on Day 1 of each 21-day cycle for 2-3 cycles in the neoadjuvant therapy and the maintenance therapy.

Chemotherapy drugs: carboplatin/cisplatin+Pemetrexed/gemcitabine/albuminpaclitaxel.

Carboplatin: AUC 5 via intravenous infusion, administered in 3-week (21 days) cycles for 2-3 cycles before and after surgery respectly.

Cisplatin: 75 mg/m2 via intravenous infusion, administered in 3-week (21 days) cycles for 2-3 cycles before and after surgery respectly.

Pemetrexed: 500mg/m2 via intravenous infusion, administered in 3-week (21 days) cycles for 2-3 cycles before and after surgery respectly.

Gemcitabine:1.0g/m2 via intravenous infusion in day1 and day8, administered in 3-week (21 days) cycles for 2-3 cycles before and after surgery respectly. Albuminpaclitaxel: 260 mg/m2 via intravenous infusion, administered in 3-week (21 days) cycles for 2-3 cycles before and after surgery respectly.

Kewei Ma

Ma Kewei

Predicting relapse and overall survival in potentially resectable Stage IIIA-IIIB Non-small Cell Lung Cancer (NSCLC) patients remains challenging. It is now widely recognized that patients with detectable MRD have a worse prognosis than those with undetectable MRD. Therefore, investigators performed this prospective clinical trial to evaluate the predictive value of MRD with increased risk of relapse and improves prediction of outcome in potentially resectable Stage IIIA-IIIB NSCLC with neoadjuvant chemoimmunotherapy. In this study, investigators will pay more attention to the long-term follow-up time and dynamic monitoring of MRD. The predictive value of MRD with Disease-free survival (DFS) rate was observed as the primary endpoint. Besides that, the correlation of MRD with major pathologic response (MPR) rate, pathologic complete response (pCR) rate，event-free survival(EFS) rate and overall survival (OS) were observed as the second endpoints. Investigators hope it will provide a new insight for these potentially resectable Stage IIA-IIIB NSCLC with neoadjuvant chemoimmunotherapy.

Detection of Minimal Residual Disease in Resectable Stage II-IIIB Non-small Cell Lung Cancer

Dynamic Monitoring of MRD in Neoadjuvant Chemoimmunotherapy for Resectable Stage II-IIIB Non-small Cell Lung Cancer：An Observational Study

Defined as the time from randomization to the occurrence of any event, including disease progression, discontinuation of treatment for any reason, or death

Defined as the time from the first dose of study drug to death due to any cause.

Defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1.

Defined as the proportion of patients with complete response, partial response, and stable disease.

Defined as the absence of residual tumor cells (RVT) in the tumor bed in the pathological response assessment of postoperative specimens after neoadjuvant therapy (the criterion of most studies also includes the absence of tumor residue in the lymph nodes).

Defined as the proportion of residual surviving tumor cells in the tumor bed in the postoperative specimen is less than or equal to 10%.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sintilimab Plus Chemotherapy Followed by dCRT in Locally Advanced ESCC	NCT03985046	Esophageal Squa...	Sintilimab plus...	18 Years - 75 Years	Fudan University
Adriamycin and Ifosfamide Combined With Sintilimab	NCT04589754	Soft Tissue Sar...	Sintilimab plus... Adriamycin-base...	14 Years - 70 Years	Sun Yat-sen University
Sintilimab Plus Chemotherapy Followed by dCRT in Locally Advanced ESCC	NCT03985046	Esophageal Squa...	Sintilimab plus...	18 Years - 75 Years	Fudan University
Detection of Minimal Residual Disease in Resectable Stage II-IIIB Non-small Cell Lung Cancer	NCT06267144	Lung Cancer	Sintilimab plus...	18 Years - 75 Years	The First Hospital of Jilin University
Detection of Minimal Residual Disease in Resectable Stage II-IIIB Non-small Cell Lung Cancer	NCT06267144	Lung Cancer	Sintilimab plus...	18 Years - 75 Years	The First Hospital of Jilin University

Spots Global Cancer Trial Database for sintilimab plus chemotherapy