Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Antibodies

Antibodies, Monoclonal

Paclitaxel

Carboplatin

Tislelizumab

Albumin-Bound Paclitaxel

Immunoglobulins

Mitogens

Tyrosine Kinase Inhibitors

Antineoplastic Agents, Immunological

Tyrosine

In the induction stage:

TQB2450 injection: 1200 mg, Intravenous drip on d1; Carboplatin injection: Area Under Curve 5mg/mL/min, Intravenous drip on d1; Paclitaxel injection: 175mg/m2, Intravenous drip on d1. The above schemes are repeated every three weeks.

In the maintenance stage:

TQB2450 injection: 1200 mg, Intravenous drip on d1; Anlotinib Hydrochloride Capsules: 10mg, orally administered every day from d1-d14.

The above schemes are repeated every three weeks.

In the induction stage:

Tislelizumab injection: 200 mg, Intravenous drip; Carboplatin injection: Area Under Curve 5mg/mL/min, Intravenous drip; Paclitaxel injection: 175mg/m2, Intravenous drip. The above schemes are repeated every three weeks.

In the maintenance stage:

Tislelizumab injection: 200 mg, Intravenous drip on d1 Placebo capsule: 0mg, orally administered every day from d1-d14. The above schemes are repeated every three weeks.

TQB2450 is a humanized monoclonal antibody targeting the programmed death ligand 1 (PD-L1), which prevents PD-L1 from binding to the PD-1 and B7.1 receptors on the surface of T cells, making T cells recover their activity, thereby enhancing the immune response.

TQB2450

Anlotinib hydrochloride is a multi-target receptor tyrosine kinase inhibitor, which can target angiogenesis related kinases, such as VEGFR 1/2/3, FGFR 1/2/3 and other tumor cell proliferation related kinases like Platelet-derived growth factor receptor (PDGFR) α/β、 C-kit, RET.

Anlotinib hydrochloride capsule

Tislelizumab injection can bind to human programmed cell death 1 (PD-1), a cell membrane protein that is mainly expressed on activated T cells and inhibits T cell activation.

Tislelizumab injection

Yuankai Shi, Doctor

Tongmei Zhang, Doctor

DingZhi Huang, Doctor

RunXiang Yang, Doctor

This is Phase 3, randomized, double-blind, parallel controlled study designed to evaluate the Progression Free Survive (PFS) of TQB2450 injection combined with Paclitaxel Injection and Carboplatin Injection Followed by TQB2450 injection combined with Anlotinib Hydrochloride Capsules versus Tislelizumab injection combined with Paclitaxel Injection and Carboplatin Injection followed by Tislelizumab injection in locally advanced (stage ⅢB/ⅢC) and metastatic or recurrent (Stage IV) squamous NSCLC subjects.The primary endpoint is PFS assessed by IRC.

TQB2450 Injection Combined With Chemotherapy Followed by Sequential Combination With Anlotinib Hydrochloride Capsule for First-line Treatment of Advanced Squamous Non-small Cell Lung Cancer.

A Phase 3, Randomized, Double-blind, Parallel Controlled, Multi-center Study to Compare the Safety and Efficacy of TQB2450 Injection Combined With Paclitaxel Injection and Carboplatin Injection Followed by TQB2450 Injection Combined With Anlotinib Hydrochloride Capsules Versus Tislelizumab Injection Combined With Paclitaxel Injection and Carboplatin Injection Followed by Tislelizumab Injection as a First-line Treatment on Patient With Advanced Squamous NSCLC.

Progression Free Survival (PFS) assessed by Independent Review Committee (IRC)

Overall survival is the time from randomization to the time of death from any cause.

Progression free survival (PFS) assessed by investigators according to The Response Evaluation Criteria In Solid Tumors 1.1 (RECIST) and iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics.

Objective response rate (ORR), assessed by investigators according to The Response Evaluation Criteria In Solid Tumors 1.1 (RECIST) and iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics.

Disease control rate (DCR)assessed by investigators according to RECIST 1.1 and iRECIST criteria

Duration of response (DOR) assessed by investigators according to RECIST1.1 and iRECIST criteria

The occurrence of adverse events (AEs) is to evaluate safety profile

The severity of adverse events (AEs) is to evaluate safety profile

The occurence of abnormal heart rate is to evaluate safety profile

The severity of abnormal heart rate is evaluated in accordance with the standard of common toxic reactions of the National Cancer Institute \[NCI CTC v5.0\].

The occurrence rate of abnormal 12 lead ECG is to evaluate safety profile. The results of PR interval were divided into low, normal and high according to the normal value range.

The results of PR interval were divided into low, normal and high according to the normal value range, and the relative baseline change was described with a cross table. The minimum or maximum observed value after the baseline is used to calculate the results after the baseline.

Descriptively summarize the results of PR examination at each visit, classify them as normal, abnormal without clinical significance, and abnormal with clinical significance, and compare them with the results of baseline, and describe them with cross classification table. The severity is evaluated in accordance with the standard of common toxic reactions of the National Cancer Institute \[NCI CTC v5.0\]

The occurrence of abnormal 12 lead ECG is to evaluate safety profile. The QRS interval results were divided into low, normal and high according to the normal value range.

The QRS interval results were divided into low, normal and high according to the normal value range, and the relative baseline change was described with a cross table. The minimum or maximum observed value after the baseline is used to calculate the results after the baseline.

Descriptively summarize the results of PR examination at each visit, classify them as normal, abnormal without clinical significance, and abnormal with clinical significance, and compare them with the results of baseline, and describe them with cross classification table. The severity is evaluated in accordance with the standard of common toxic reactions of the National Cancer Institute \[NCI CTC v5.0\]

The occurrence rate of Abnormal 12 lead ECG is to evaluate safety profile. The results of QT interval were divided into low, normal and high according to the normal value.

The results of QT interval were divided into low, normal and high according to the normal value range, and the relative baseline change was described with a cross table. The minimum or maximum observed value after the baseline is used to calculate the results after the baseline.

Descriptively summarize the results of PR examination at each visit, classify them as normal, abnormal without clinical significance, and abnormal with clinical significance, and compare them with the results of baseline, and describe them with cross classification table. The severity is evaluated in accordance with the standard of common toxic reactions of the National Cancer Institute \[NCI CTC v5.0\]

The occurrence of Abnormal 12 lead ECG is to evaluate safety profile. The results of QTc interval were divided into low, normal and high according to the normal value.

The results of QTc interval were divided into low, normal and high according to the normal value range, and the relative baseline change was described with a cross table. The minimum or maximum observed value after the baseline is used to calculate the results after the baseline.

Descriptively summarize the results of PR examination at each visit, classify them as normal, abnormal without clinical significance, and abnormal with clinical significance, and compare them with the results of baseline, and describe them with cross classification table. The severity is evaluated in accordance with the standard of common toxic reactions of the National Cancer Institute \[NCI CTC v5.0\]

The occurrence of serious adverse events (SAEs) is to evaluate safety profile

The severity of serious adverse events (SAEs) is to evaluate safety profile

QLQ-C30 is a quality of life questionnaire to help understand the physical condition of the subjects. The subjects need to answer them in person and circle the number that best reflects their situation. Among them, 1 represents no, 2 represents a little, 3 represents some, and 4 represents a lot. Questions 29 and 30 need to choose the most suitable number from 1 to 7 and draw a circle. The other 1 represents very poor, and 7 represents very good. Questions 29 and 30 need to choose the most suitable number from 1 to 7 and draw a circle. The other 1 represents very poor, and 7 represents very good.

QLQ-LC13 is a quality of life questionnaire to help understand the physical condition of the subjects. The subjects need to answer them in person and circle the number that best reflects their situation. Among them, 1 represents no, 2 represents a little, 3 represents some, and 4 represents a lot.

EQ-5D assessment pro is a quality of life questionnaire, which has five questions that need to be answered by the subjects themselves, choose the answer that best reflects their health, and mark the point on the set scale that best represents their health, of which 100 represents the best condition and 0 represents the worst condition.

It's a parameter to evaluate the immunogenicity of TQB2450 injection

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Digestive System Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Capecitabine

Immune Checkpoint Inhibitors

Raltitrexed

Oxaliplatin

The blood supplying artery of the tumor is selected for drug injection with Oxaliplatin 85mg/m2 combined Raltitrexed 3mg/m2. After drug injection, gelatin sponge is used for embolization.

Arterial chemoembolization

Tislelizumab Injection 200mg i.v. q3w, A total of 3 cycles are administered.

Tislelizumab Injection

Capecitabine 1,000 mg/m2 bid, po, on days 1-14 Oxaliplatin: 130 mg/m2, i.v. day 1 Cycles are repeated on day 22. A total of 3 cycles are administered.

XELOX

Pelvic MRI

Surgical treatment for patients who meet the surgical conditions

Laparoscopic radical resection of rectal cancer

Yiqun Fan

Rectal cancer is one of the common malignant tumors of the digestive tract. Some patients with rectal cancer are already advanced tumors when they are first diagnosed. At this time, the tumor has local infiltration, the probability of recurrence and metastasis after surgical resection is high, and even radical tumor resection cannot be performed. Neoadjuvant chemotherapy and radiotherapy have become one of the important treatment methods for these patients to increase the rate of radical tumor resection. However, a series of side effects of neoadjuvant radiotherapy can even continue after the end of radiotherapy, and even increase the incidence of postoperative complications. Superselective arterial interventional chemotherapy has been widely used in preoperative neoadjuvant chemotherapy for various tumors, and its efficacy in rectal cancer has also been confirmed. In addition, as a hot spot in tumor treatment, tumor immunotherapy has shown exciting effects in the NICHE study of neoadjuvant immunotherapy before colon cancer surgery. Moreover, Oxaliplatin is a classic chemotherapeutic drug that induces Immunogenic cell death effects, which induce antitumor immunity.

Therefore, in order to optimize the preoperative neoadjuvant therapy plan, the investigators propose a treatment method of superselective arterial chemoembolization combined with immunotherapy and systemic chemotherapy, in order to obtain better preoperative conversion therapy effect and reduce the adverse reactions of neoadjuvant therapy.

Neoadjuvant Arterial Embolization Chemotherapy Combined PD-1 Inhibitor for Locally Advanced Rectal Cancer

Phase Ⅱ Clinical Trial of Neoadjuvant Arterial Embolization Chemotherapy Combined Immune Checkpoint Inhibitor for Locally Advanced Rectal Cancer: A Single Arm Prospective Sturdy

Tumor regression on imaging after neoadjuvant therapy

There is no histological evidence of malignancy in the primary tumor and metastatic regional lymph nodes, or there is only a carcinoma in situ component

Time from postoperative disease-free survival to disease recurrence or metastasis

Tumor regression on pathology after neoadjuvant therapy

Second Affiliated Hospital, School of Medicine, Zhejiang University

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Dacarbazine

Antineoplastic Agents, Alkylating

Alkylating Agents

Tislelizumab combined with dacarbazine in the treatment of advanced melanoma.

Efficacy of tislelizumab or tislelizumab combined with dacarbazine in the treatment of advanced malignant melanoma.

Wang Jiaqiang, Dr.

Zhichao Tian, Dr.

A total of 40 subjects who had not received systemic treatment or chemotherapy in the past and were allowed to receive adjuvant or neoadjuvant treatment for advanced melanoma received tirelizumab combined with dacarbazine for 4-6 cycles to evaluate the efficacy, safety and prognosis of tirelizumab combined with dacarbazine in the treatment of advanced melanoma.

In henan province tumor hospital into the group of 40 cases always will not accept any systemic therapy or chemotherapy, allowed to always have a recurrence of adjuvant or neoadjuvant therapy sensitive sensitive relapse (referring to more than six months after the last chemotherapy recurrence) of unresectable melanoma metastatic/operation subjects, accept for LeiLiZhu a joint resistance of kappa oxazine treatment 4-6 cycles, To evaluate the efficacy, safety and prognosis of tislelizumab combined with dacarbazine in the treatment of advanced melanoma.

PD-1 Antibody Tislelizumab Combined With Dacarbazine in the Treatment of Advanced Melanoma

A Single-center, Open-arm, Single-arm Phase II Trial of the PD-1 Antibody Tirelizumab Plus Dacarbazine as First-line Treatment for Advanced Melanoma

Until the tumor progresses or the patient dies or is lost to follow-up or cannot tolerate it

From the start of treatment to the onset of disease progression or death of the patient

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
TQB2450 Injection Combined With Chemotherapy Followed by Sequential Combination With Anlotinib Hydrochloride Capsule for First-line Treatment of Advanced Squamous Non-small Cell Lung Cancer.	NCT05718167	Advanced Squamo...	TQB2450 Anlotinib hydro... Tislelizumab in...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Neoadjuvant Arterial Embolization Chemotherapy Combined PD-1 Inhibitor for Locally Advanced Rectal Cancer	NCT05420584	Rectal Neoplasm...	Arterial chemoe... Tislelizumab In... XELOX Pelvic MRI Laparoscopic ra...	18 Years - 75 Years	The Fourth Affiliated Hospital of Zhejiang University School of Medicine
TQB2450 Injection Combined With Chemotherapy Followed by Sequential Combination With Anlotinib Hydrochloride Capsule for First-line Treatment of Advanced Squamous Non-small Cell Lung Cancer.	NCT05718167	Advanced Squamo...	TQB2450 Anlotinib hydro... Tislelizumab in...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
TQB2450 Injection Combined With Chemotherapy Followed by Sequential Combination With Anlotinib Hydrochloride Capsule for First-line Treatment of Advanced Squamous Non-small Cell Lung Cancer.	NCT05718167	Advanced Squamo...	TQB2450 Anlotinib hydro... Tislelizumab in...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Neoadjuvant Arterial Embolization Chemotherapy Combined PD-1 Inhibitor for Locally Advanced Rectal Cancer	NCT05420584	Rectal Neoplasm...	Arterial chemoe... Tislelizumab In... XELOX Pelvic MRI Laparoscopic ra...	18 Years - 75 Years	The Fourth Affiliated Hospital of Zhejiang University School of Medicine
PD-1 Antibody Tislelizumab Combined With Dacarbazine in the Treatment of Advanced Melanoma	NCT05466474	Advanced Melano...	Tislelizumab In...	18 Years - 72 Years	Henan Cancer Hospital

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