Neoplasms

Skin and Connective Tissue Diseases

All Conditions

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

Acral Lentiginous Melanoma

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Imidazole

Apatinib

Antibodies

Antibodies, Monoclonal

Temozolomide

Immunoglobulins

Endothelial Growth Factors

Mitogens

Dacarbazine

Tyrosine Kinase Inhibitors

Alkylating Agents

Antineoplastic Agents, Alkylating

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody

SHR1210

apatinib Mesylate is a small molecule tyrosine kinase inhibitor,Through selectively inhibiting the tyrosine kinase activity of the vascular endothelial growth factor receptor 2 (VEGFR-2).

apatinib mesylate

Temozolomide is an imidazole tetrazine derivative of the alkylating agent dacarbazine.Temozolomide is not directly active but undergoes rapid, spontaneous, non-enzymatic conversion at physiologic pH to the cytotoxic compound, monomethyl triazeno imidazole carboxamide (MTIC).

Temozolomide Injection

It is a single-center,exploratory clinical trial aimed to evaluate the objective response rate (ORR) of Camrelizumab combined with apatinib and Temozolomide as First Line Therapy in Advanced Acral Melanoma.

Camrelizumab Plus Apatinib and Temozolomide as First Line Therapy in Advanced Acral Melanoma

Camrelizumab Plus Apatinib and Temozolomide as First Line Therapy in Advanced Acral Melanoma：a Single-center, Exploratory Clinical Study

Peking University Cancer Hospital & Institute

Associate Director of Peking University Cancer Hospital

Symptoms and General Pathology

Neoplasm Metastasis

Breast Neoplasms

Breast Diseases

Anti-Infective Agents

Capecitabine

Paclitaxel

Bevacizumab

Everolimus

Fulvestrant

Albumin-Bound Paclitaxel

Sirolimus

Aromatase Inhibitors

Poly(ADP-ribose) Polymerase Inhibitors

Temsirolimus

MTOR Inhibitors

Androgen Receptor Antagonists

Fluzoparib

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

If a patient were NF1 mutated, she would receive SHR7390(MEK1/2 inhibitor) and Faminitib.

If a patient were gBRCA mutated, she would receive SHR3162 (PARP inhibitor)and SHR6390(CDK4/6 inhibitor) .

If a patient were HER2 activated mutated and had not previously used capecitabine, she would receive Pyrotinib and Capecitabine , while if the patient have previously used capecitabine, she would only use pyrotinib as a single agent.

If a patient were PDGFRb mutated, she would receive Faminitib.

In the arm which IHC showed CD8 ≥10%, this arm will be subdivided into 6 sub-arms, in which Arm 5A-4D, we choose the patients who had CDK4/6 inhibitor before while in Arm 5E, we choose the patients who secondarily resistant to adjuvant endocrine therapy , and in Arm 5FF, we choose the patients who is in stage IV without precious treatment or sensitively recurrence. A patient would receive SHR1210(PD-1 antibody) ,nab-paclitaxel and Faminitib in Arm-5A. A patient would receive SHR1210(PD-1 antibody) and VEGF inhibitor in Arm-5B. A patient would receive SHR1701(PD-L1/TGF-βRII inhibitor) in Arm-5C. A patient would receive SHR1701(PD-L1/TGF-βRII inhibitor) and SHR6390(CDK4/6 inhibitor) in Arm-5D. A patient would receive SHR1210(PD-1 antibody) and SHR6390(CDK4/6 inhibitor) and SERD in Arm-5E. A patient would receive SHR1210(PD-1 antibody) and SHR6390(CDK4/6 inhibitor) and AI in Arm-5F.

If a patient had any PAM pathway mutation, she would receive Everolimus(mTOR inhibitor) combined with nab-paclitaxel.

If a patient's IHC showed AR≥10% , she would receive SHR2554(EZH2 inhibitor) and SHR3680(AR inhibitor).

In this cohort, a patient would receive SHR2554(EZH2 inhibitor) and SHR3162 (PARP inhibitor).

In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with SHR1701(anti-PD-L1/TGF-βRII bifunctional fusion protein) .

SHR7390

Famitinib

SHR3162

HER1 / HER2 receptor tyrosine kinase inhibitor

Pyrotinib

In Arm III, if the patient had not previously used capecitabine,she would receive pyrotinib and capecitabine, if the patients have previously used capecitabine, she would only used pyrotinib as a single agent.

Nab paclitaxel

SHR2554

SHR3680

SHR6390

anti-PD-L1/TGF-βRII bifunctional fusion protein

SHR1701

SERD

VEGFi

Zhi-Ming Shao

Zhong-Hua Wang

Zhimin Shao, MD, PhD

This study is a prospective, single-center, open-label, umbrella-shaped phase II clinical study for patients with HR+/HER2- endocrine-resistant advanced breast cancer.

Seven precision treatment cohorts, which targeting NF1 mutation, gBRCA mutation,HER2 mutation, FDGFRb mutation PAM pathway mutations, CD8 and AR, as long as an epigenetic therapy cohort and a combined immunization cohort were initially set up based on gene expression profiles and molecular pathways. The main purpose is to screen valuable treatment cohorts and prepare for subsequent randomized controlled phase III clinical studies with larger sample size.

Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer

Precision Treatment of Luminal Advanced Breast Cancer Based on Molecular Subtyping

The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)

the percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the evaluable subjects

time to progressive disease (according to RECIST1.1)

Fudan University

Professor, Key Laboratory of Breast Cancer in Shanghai, Department of Breast Surgery

Death

Antirheumatic Agents

Analgesics

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Interleukin-2

Analgesics, Non-Narcotic

Peripheral blood lymphocytes will be collected and neoantigen reactive T cells(NRTs) will be generated in the laboratory;Both Fludarabine 30mg/m2/D and Cyclophosphamide 300mg/m2/D will be i.v. for 3 days before cell infusion; NRTs 0.5\~1 x 10\^10, will be i.v.Q3 weeks for total 4 doses;programmed cell death-1（PD1） inhibitor SHR-1210,200mg,will be i.v. Q3 weeks for total 4 doses,2 day2 prior to each NRTs infusion;Interleukin-2 (IL-2) will be continuous intravenous infused since the first day of the cell infusion for 5 consecutive days, 4000,000 international unit per day.All Patients will receive a total of 4 cycles of treatment.

Neoantigen Reactive T Cells in an expected volume of 100 milliliter（mL） will be given by intravenous injection over 2-10 minutes through either a peripheral or a central line.

Neoantigen Reactive T Cells(NRTs)

SHR-1210 200mg will be administered as an intravenous infusion over 60 minutes.

SHR-1210

Fludarabine(FLU) 30mg/m2/d×3d，3 days prior to each NRTs infusion as preconditional chemotherapy.

Cyclophosphamide(CTX) 300mg/m2/d×3d，3 days prior to each NRTs infusion as preconditional chemotherapy.

Interleukin-2(IL-2)will be continuous intravenous infused since the first day of the cell infusion for 5 consecutive days, 4000,000 international unit per day.

Baorui Liu, M.D & Ph.D

Zhengyun Zou, M.D & Ph.D

Baorui Liu, M.D. & Ph.D

Zhengyun Zou, M.D. & Ph.D

The purpose of this study is to see the safety and efficient of neoantigen reactive T cells (NRTs) combined with programmed cell death-1(PD-1) inhibitor（SHR-1210）in the treatment of Chinese patients with advanced refractory solid tumors.

The tumor-specific "none-self" immunogenic neoantigens encoded by either viral genes or somatic mutation genes, possess the potential to induce specific anti-cancer immunity, including cellular and humoral immune responses. Today, numerous clinical trials demonstrate that although these "none-self" antigens initiate the antigen-specific immunoglobulin G antibodies and cluster of differentiation 4（CD4）+/cluster of differentiation 8（CD8）+T-cells response, not all of them show a clinical benefit in the response rate, progression-free survival or overall survival.Immune tolerance induced by PD-1 or programmed cell death-ligand1（ PD-L1）maybe play a vital role for these negative outcomes.Personalized cell therapy plus checkpoint inhibitors maybe own a breakthrough in the treatment of those malignant diseases without standard options.Our center has successfully established a new method for preparing personalized neoantigen reactive T cells(NRTS) for adoptive cell therapy(ACT). Today, we will carry out a single center single arm clinical prospective study of NRTs combined with PD-1 inhibitor(SHR-1210) for the treatment of Chinese patients with advanced refractory solid tumors. Participants are assigned to receive 4 circles of cell therapy,and prior to each cycle's immunocytes treatment,preconditional chemotherapy and SHR-1210 will be carried out, and IL-2 continuous intravenous infusion（CIV） will also be given for 5 consecutive days after each time's cell infusion. The safety and clinical response rate（RR） are evaluated. Biomarkers and immunological markers are also monitored.

Neoantigen Reactive T Cells Combined With SHR-1210 for Chinese Patients With Advanced Refractory Solid Tumors

Single Center Single Arm Clinical Prospective Study of Neoantigen Reactive T Cells (NRTs) Combined With Programmed Cell Death-1（PD-1） Inhibitor in the Treatment of Chinese Patients With Advanced Refractory Solid Tumors

the duration is measured from the time of treatment to the time of death

T cells in the peripheral blood stimulated by tumor antigens for 24 hr，and then Interferon-gama secretion is measured

cytokines are measured by flow cytometry(FCM)

using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in patients

Response Rate（RR） will be evaluated according Response Evaluation Criteria in Solid Tumors

the duration of progression free survival is measured from the time of treatment to the first date that recurrent or progressive disease or for any reason of death is objectively documented.

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Chief physician

Jun Guo, MD

Jun Guo

the investigators launched this exploratory study to evaluate the objective response rate (ORR) of SHR-1210 combined with apatinib mesylate in the first-line treatment of patients with advanced acral melanoma.

PD-1 Antibody SHR-1210 Combined With Apatinib of First-line Treatment of Advanced Acral Melanoma

A Phase II Study of PD-1 Antibody SHR-1210 Combined With Apatinib of First-line Treatment of Advanced Acral Melanoma

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Angiogenesis Inhibitors

Drug: SHR-1210 SHR-1210 was administered 200mg iv every 2 weeks Drug: Apatinib Apatinib was administered 500mg oral daily during the first 2 weeks and then 250 mg qd

Zhang Yanqiao, PHD

Wang Guangyu, PHD

This is a Phase II , Open-label , Investigator-initiated Trail of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib in Patients With unresectable Hepatocellular Carcinoma.

This study aims to evaluate the safety and efficacy of SHR-1210 combination with Apatinib as a preoperative treatment of unresectable HCC.

A Trial of SHR-1210 in Combination With Apatinib in Patients With Unresectable HCC

A Phase II , Open-label , Investigator-initiated Trail of An Anti-PD-1 Inhibitor SHR-1210 in Combination With Apatinib in Patients With Unresectable Hepatocellular Carcinoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Camrelizumab Plus Apatinib and Temozolomide as First Line Therapy in Advanced Acral Melanoma	NCT04397770	Melanoma	SHR1210 apatinib mesyla... Temozolomide In...	18 Years - 75 Years	Peking University Cancer Hospital & Institute
Camrelizumab Plus Apatinib and Temozolomide as First Line Therapy in Advanced Acral Melanoma	NCT04397770	Melanoma	SHR1210 apatinib mesyla... Temozolomide In...	18 Years - 75 Years	Peking University Cancer Hospital & Institute
Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer	NCT04355858	Breast Cancer Metastatic Canc...	SHR7390 Famitinib SHR3162 Pyrotinib Capecitabine SHR1210 Everolimus Nab paclitaxel SHR2554 SHR3680 SHR6390 SHR1701 SERD AI VEGFi	18 Years - 75 Years	Fudan University
Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer	NCT04355858	Breast Cancer Metastatic Canc...	SHR7390 Famitinib SHR3162 Pyrotinib Capecitabine SHR1210 Everolimus Nab paclitaxel SHR2554 SHR3680 SHR6390 SHR1701 SERD AI VEGFi	18 Years - 75 Years	Fudan University
Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer	NCT04355858	Breast Cancer Metastatic Canc...	SHR7390 Famitinib SHR3162 Pyrotinib Capecitabine SHR1210 Everolimus Nab paclitaxel SHR2554 SHR3680 SHR6390 SHR1701 SERD AI VEGFi	18 Years - 75 Years	Fudan University
Neoantigen Reactive T Cells Combined With SHR-1210 for Chinese Patients With Advanced Refractory Solid Tumors	NCT03171220	Advanced Malign...	Neoantigen Reac... SHR-1210 Fludarabine Cyclophosphamid... Interleukin-2	18 Years - 75 Years	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
PD-1 Antibody SHR-1210 Combined With Apatinib of First-line Treatment of Advanced Acral Melanoma	NCT03955354	Melanoma	SHR1210 apatinib mesyla...	18 Years - 75 Years	Peking University Cancer Hospital & Institute
A Trial of SHR-1210 in Combination With Apatinib in Patients With Unresectable HCC	NCT03793725	Hepatocellular ...	SHR1210 Apatinib	18 Years - 75 Years	Harbin Medical University
A Trial of SHR-1210 in Combination With Apatinib in Patients With Unresectable HCC	NCT03793725	Hepatocellular ...	SHR1210 Apatinib	18 Years - 75 Years	Harbin Medical University

Spots Global Cancer Trial Database for shr1210

Every month we try and update this database with for shr1210 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for shr1210

Every month we try and update this database with for shr1210 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for shr1210 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.