Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Antibodies

Pemetrexed

Immunomodulating Agents

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Participants will receive neoadjuvant Carrelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection and adjuvant Carrelizumab for 16 cycles.

Camrelizumab: 200mg, IV, day 1 of each 21-day cycle, neoadjuvant therapy : 3 cycles; Adjuvant therapy: 16cycles.

Carrelizumab

Nab-paclitaxel: 260mg/m\^2, IV, day 1 of each 21-day cycle, 3 cycles; Pemetrexed: 500 mg/m\^2, IV, day 1 of each 21-day cycle, 3 cycles.

Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel(Squamous NSCLC)

Carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 i.v. on day 1 of each 21-day cycle for 3 cycles.

Surgery must be done within the 4th-6th week from day 1 cycle 3 of neoadjuvant treatment (4-6 weeks after day 1 of cycle 3)

Surgery

Yongde Liao, PhD

Mingliang Wang, MD

The purpose of this study is to evaluate the safety and efficacy of Camrelizumab in combination with platinum doublet neoadjuvant chemotherapy before surgery \[neoadjuvant phase\], followed by Camrelizumab alone after surgery \[adjuvant phase\] in participants with unresectable stage III non-small cell lung cancer.

Concurrent chemoradiotherapy is the recommended therapeutic approach for patients with unresectable stage III non-small cell lung cancer(NSCLC), although surgery offers the chance of cure. With combined radiation and chemotherapy, the prognosis of unresectable stage III NSCLC remains poor. Immunotherapy combined with chemotherapy has been shown to be efficacious as treatment for advanced non-squamous non-small-cell lung cancer (NSCLC) without targetable genetic aberrations. Camrelizumab, a humanised monoclonal antibody against PD-1, has shown its efficacy in the treatment of advanced NSCLC. This study is to studying neoadjuvant camrelizumab plus double platinum based chemotherapy followed by surgery to see how well it works in treating patients with unresectable stage III NSCLC.

Neoadjuvant Immunotherapy and Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC

Induction Therapy With Chemoimmunotherapy Followed by Surgery for Unresectable Stage III Non-small Cell Lung Cancer: a Single-center, Single-arm, Prospective Clinical Study

MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.

Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.

The incidences and types of adverse events that occur during neoadjuvant therapy and perioperative period (within postoperative 30 days and 90 days) will be evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Wuhan Union Hospital, China

Digestive System Diseases

Rare Diseases

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

Cisplatin

Study drugs were administered intravenously on the first day of each cycle. Administered sequentially: carrelizumab, 200mg/time, paclitaxel, 50mg/m2, cisplatin, 25mg/m2, chemotherapy once a week, a total of 5 doses, carrelizumab every three weeks until PD or intolerable, up to 2 years, simultaneous radiotherapy at the first dose, the total dose of radiotherapy is 50.4Gy, completed in 28 divided doses, 1.8Gy each time, 5 times a week.

Placebo: 200 mg intravenously given with Q3W until PD or intolerable, carrelizumab/placebo for up to 2 years.

Paclitaxel: 50mg/m2, iv, D1, 8, 15, 22, 29, once a week, a total of 5 times. cisplatin: 25mg/m2,iv, D1, 8, 15, 22, 29, once a week, a total of 5 doses. Radiotherapy: total dose of 50.4 Gy, completed in 28 divided doses of 1.8 Gy each time, 5 times a week.

50mg/m2,iv, D1, 8, 15, 22, 29, once a week, a total of 5 times

Paclitaxel injection

25mg/m2，iv， D1、8、15、22、29，once a week, a total of 5 times

Radiotherapy was given simultaneously at the time of the first dose, and the total dose of radiotherapy was 50.4 Gy, which was completed in 28 divided doses of 1.8 Gy each time, 5 times a week.

Concurrent chemoradiotherapy

Xiaolin MM GE

This study is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the efficacy and safety of carrelizumab plus concurrent chemoradiotherapy compared with placebo plus concurrent chemoradiotherapy in the treatment of patients with inoperably advanced esophageal cancer, and to explore the relationship between PD-L1 expression and efficacy in tumor tissues. Experimental group: carrelizumab in combination with concurrent chemoradiotherapy PD-1: carrelizumab: 200 mg/3W Chemotherapy: Paclitaxel: 50 mg/m2/W Cisplatin: 25mg/m2/W Radiotherapy: 50.4 Gy / 28 f Chemotherapy drugs are used for 5 cycles, and carrelibizumab is used for up to 24 months until PD or is intolerable Control group: placebo-resistant in combination with chemoradiotherapy placebo: 200 mg/3 W Chemotherapy: Paclitaxel: 50 mg/m2/W Cisplatin: 25mg/m2/W Radiotherapy: 50.4 Gy / 28 f Chemotherapy drugs are used for 5 cycles, and carrelibizumab is used for up to 24 months until PD or is intolerable

Experimental group: carrelizumab in combination with concurrent chemoradiotherapy PD-1: carrelizumab: 200 mg/3W Chemotherapy: Paclitaxel: 50 mg/m2/W Cisplatin: 25mg/m2/W Radiotherapy: 50.4 Gy / 28 f Chemotherapy drugs are used for 5 cycles, and carrelibizumab is used for up to 24 months until PD or is intolerable Control group: placebo-resistant in combination with chemoradiotherapy placebo: 200 mg/3 W Chemotherapy: Paclitaxel: 50 mg/m2/W Cisplatin: 25mg/m2/W Radiotherapy: 50.4 Gy / 28 f Chemotherapy drugs are used for 5 cycles, and carrelibizumab is used for up to 24 months until PD or is intolerable

Carrelizumab Combined With Concurrent Radiotherapy and Chemotherapy for Unresectable Esophageal Squamous Cell Carcinoma

A Randomized, Double-blind, Parallel-controlled, Multicenter Phase III Clinical Study

IRC stands for Independent Review Committee Assessment，Progression-free disease as assessed by an independent review committee Progression-free survival refers to the time from randomization to the first occurrence of disease progression or death from any cause

Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.

Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission

The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death.

The First Affiliated Hospital with Nanjing Medical University

Cholangiocarcinoma

Adenocarcinoma

Bile Duct Cancer

In this study, carrilizumab combined with sovantinib in the second-line treatment of patients with advanced or metastatic cholangiocarcinoma with single arm, open, Exploratory clinical trials.The specific treatment regimen was carrilizumab 200mg Q3W d1; Sofantinib: 300mg,Take orally, once a day, continuously. Treatment continues or until disease progression occurs or the patient becomes intolerant to treatment regimens.The efficacy was evaluated every 2 cycles.

Solfantinib

yangwei fan, phd

rui qu

enxiao li, PHD

The incidence of cholangiocarcinoma is high, the radical resection rate is low, the postoperative recurrence is easy, the prognosis is poor.Gemcitabine combined with cisplatin (GC) is the standard first-line treatment for patients with advanced biliary carcinoma, and up to now there is no standard second-line treatment Commend.Carrilizumab was highly effective in previous studies,Its combined GEMOX protocol has been published in the "Guidelines for the Diagnosis and Treatment of Gallbladder Cancer (2019 Edition)" and the "China Clinical Oncology" The Society's (CSCO) Guidelines for the Diagnosis and Treatment of Biliary alignancies 2020 is recommended for the first-line treatment of advanced biliary cancers.Solfantinib is targeted at VEGFR1, 2, 3, FGFR1And CSF1R highly selective small molecule targeted therapy drugs. Data from a preliminary phase 2 clinical trial observed sofantinib therapy Survival benefits of cholangiocarcinoma patients in China.

In this study, carrilizumab combined with suvantinib in the second-line treatment of patients with advanced or metastatic cholangiocarcinoma with single arm, open, Exploratory clinical trials. The study plan enlists 60 patients with unresectable or recurrent disease confirmed by histopathology or cytology Or metastatic cholangiocarcinoma (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, distal cholangiocarcinoma). Past acceptance of standard containing Systematic internal medicine anti-tumor therapy with gemcitabine regimen met the inclusion criteria of this study, and carrilizumab combined with cord was given Vantinib oral therapy. The specific treatment regimen was carrilizumab 200mg Q3W d1; Solventinib: 300mg, Orally, once a day, continuously. Treatment continues or until disease progression occurs or the patient becomes intolerant to the treatment regimen The efficacy was evaluated every 2 cycles. The main evaluation of carrilizumab combined with suvantinib in second-line treatment was advanced or Progression-free survival (PFS) in patients with metastatic cholangiocarcinoma.

Carlizumab Plus Sovantinib in Second-line Treatment of Advanced or Metastatic Cholangiocarcinoma

Exploratory Clinical Study of Carlizumab Plus Sovantinib in Second-line Treatment of Advanced or Metastatic Cholangiocarcinoma

Disease control rate Disease control rate Disease control rate

First Affiliated Hospital Xi'an Jiaotong University

Symptoms and General Pathology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Recurrence

Nasopharyngeal Carcinoma

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Gemcitabine

Antimetabolites

QL1706

li Zhang, Doctor

This is a randomized, open, multicenter phase II/III trial to compare the efficacy and safety of QL1706 and carrilizumab combined with gemcitabine and cisplatin in first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.

This is a randomized, open, multicenter phase II/III trial to compare the efficacy and safety of QL1706 and carrilizumab combined with gemcitabine and cisplatin in first-line treatment of recurrent or metastatic nasopharyngeal carcinoma. The study is divided into two parts.

The first part is a phase II, single-arm study with an introductory safety phase, which is planned to enroll 30 subjects with nasopharyngeal carcinoma treated with first-line QL1706 in combination with gemcitabine and cisplatin. The primary objective of the first part is to evaluate the safety and tolerability of QL1706 combined with gemcitabine and cisplatin in the first-line treatment of patients with recurrent or metastatic nasopharyngeal carcinoma.

The second part is a phase III randomized, controlled study. The study plans to enroll 430 subjects, who will be randomized in a 1:1 ratio to a trial group of QL1706 in combination with gemcitabine and cisplatin and a control group of carrilizumab in combination with gemcitabine and cisplatin. The primary objective of the second part was to compare the effectiveness of QL1706 with that of carrilizumab combined with gemcitabine and cisplatin, respectively, in the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.

A Phase II/III Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Nasopharyngeal Carcinoma

A Randomized, Open, Multicenter Phase II/III Trial to Compare the Efficacy and Safety of QL1706 and Carrilizumab Combined With Gemcitabine and Cisplatin in First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

The PFS assessed by Blinded independent central review (BICR)

The ORR assessed by BICR and Investigator

The DOR assessed by BICR and Investigator

The DCR assessed by BICR and Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoadjuvant Immunotherapy and Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC	NCT04943029	Non Small Cell ...	Carrelizumab Pemetrexed (Non... Carboplatin Surgery	18 Years - 70 Years	Wuhan Union Hospital, China
Carrelizumab Combined With Concurrent Radiotherapy and Chemotherapy for Unresectable Esophageal Squamous Cell Carcinoma	NCT06048926	Esophageal Squa...	Carrelizumab Paclitaxel inje... Cisplatin Concurrent chem...	18 Years - 75 Years	The First Affiliated Hospital with Nanjing Medical University
Carrelizumab Combined With Concurrent Radiotherapy and Chemotherapy for Unresectable Esophageal Squamous Cell Carcinoma	NCT06048926	Esophageal Squa...	Carrelizumab Paclitaxel inje... Cisplatin Concurrent chem...	18 Years - 75 Years	The First Affiliated Hospital with Nanjing Medical University
Neoadjuvant Immunotherapy and Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC	NCT04943029	Non Small Cell ...	Carrelizumab Pemetrexed (Non... Carboplatin Surgery	18 Years - 70 Years	Wuhan Union Hospital, China
Carlizumab Plus Sovantinib in Second-line Treatment of Advanced or Metastatic Cholangiocarcinoma	NCT05697237	Cholangiocarcin...	Carrelizumab Solfantinib	18 Years - 75 Years	First Affiliated Hospital Xi'an Jiaotong University
A Phase II/III Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Nasopharyngeal Carcinoma	NCT05576272	Nasopharyngeal ...	QL1706 Carrelizumab Gemcitabine Cisplatin	18 Years -	Qilu Pharmaceutical Co., Ltd.
Neoadjuvant Immunotherapy and Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC	NCT04943029	Non Small Cell ...	Carrelizumab Pemetrexed (Non... Carboplatin Surgery	18 Years - 70 Years	Wuhan Union Hospital, China

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