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SHR-1701 Simultaneously Combined with High Fractionation and Low-dose Radiotherapy

SHR1701

JinMing Yu, PhD

This study is a single center, single arm, open study design. The main purpose of this study is to evaluate the tolerance and efficacy of SHR1701 with synchronous radiotherapy in patients with metastatic non-small cell lung cancer who have failed after systematic treatment. Large fraction radiotherapy is given to all lesions as much as possible, and low-dose radiotherapy is given to the lesions that cannot be tolerated or have no obvious benefit.

A Trial of SHR1701 Combined With Radiotherapy for Metastatic Non-small Cell Lung Cancer Failure After First-line Treatment

Director of Shandong Cancer Hospital and Institute

Shandong Cancer Hospital and Institute

President of Shandong Cancer Hospital and Institute

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Neoplasm Metastasis

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

Anti-Infective Agents

Amino Acids

Capecitabine

Paclitaxel

Bevacizumab

Everolimus

Fulvestrant

Albumin-Bound Paclitaxel

Sirolimus

Aromatase Inhibitors

Tyrosine Kinase Inhibitors

Poly(ADP-ribose) Polymerase Inhibitors

Temsirolimus

MTOR Inhibitors

Androgen Receptor Antagonists

Fluzoparib

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Tyrosine

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.

SHR1210

Nab paclitaxel

SHR2554

SHR3680

SHR6390

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

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)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Trial of SHR1701 Combined With Radiotherapy for Metastatic Non-small Cell Lung Cancer Failure After First-line Treatment	NCT04560244	Non-Small-Cell ...	SHR1701	18 Years - 75 Years	Shandong Cancer Hospital and 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
A Trial of SHR1701 Combined With Radiotherapy for Metastatic Non-small Cell Lung Cancer Failure After First-line Treatment	NCT04560244	Non-Small-Cell ...	SHR1701	18 Years - 75 Years	Shandong Cancer Hospital and Institute

Spots Global Cancer Trial Database for shr1701

Every month we try and update this database with for shr1701 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 shr1701

Every month we try and update this database with for shr1701 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 shr1701 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.