Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Oxaliplatin

Antimetabolites

Patients with high-risk locally advanced rectal cancer will receive chemotherapy and SHR-1210 before chemoradiaton, after chemoradiaton, patient will receive consolidation chemotherapy. This arm is called Total Neoadjuvant Treatment (TNT) plus SHR-1210. The neoadjuvant chemotherapy regimen is designed as 3 cycles of CapeOX ( Capecitabine + Oxaliplatin ) plus SHR-1210 over a period of approximately 8 weeks. Tumor response will be evaluated after chemotherapy. Then patients will undergo 22f-IMRT (Intensity modulated radiotherapy) with capecitabine. Patients will receive two more cycles of consolidation CapeOX if tolerable when there was no progressed disease in induction CapeOX.

Finally, patients will receive TME (Total mesorectal excision) following TNT+SHR1210 if no metastasis occurs.

Patients will receive 3 cycles induction CapeOX and SHR-1210

SHR-1210

CapeOX is a combination chemotherapy regimen with OXA and CAPE, patients with high-risk rectal cancer will receive 3 cycles induction CapeOX and SHR-1210, intensity modulated radiotherapy with concurrent capecitabine and 2 cycles consolidation CapeOX and total mesorectal excision.

patients will receive intensity modulated radiotherapy with capecitabine

Intensity modulated radiotherapy

Patients will receive TME (Total mesorectal excision) following TNT+SHR1210 if no metastasis occurs.

Total mesorectal excision

Yingjie LI

Yingjie Li, M.D.

Aiwen Wu, M.D.

This study is designed to test the efficacy and safety of Total Neoadjuvant Treatment plus SHR1210（an anti-PD-1 Inhibitor) for High-risk locally advanced Rectal Cancer, Meanwhile, screening effective Biomarker base on neoantigen.

The combined treatment model of neoadjuvant chemoradiotherapy treatment + radical rectal resection + adjuvant therapy has become the standard treatment model for locally advanced mid-low rectal cancer, However, the existing evidence shows that this comprehensive treatment method has reached the upper limit of efficacy and cannot continue to reduce the metastatic rate and improve the survival rate.

Recent studies have shown that PD-1 antibody inhibitors have excellent curative effects on the treatment of a variety of tumors and have good safety.

This study is a single-arm, single-center, prospective, phase II clinical study. It is designed to test the efficacy and safety of Total Neoadjuvant chmoradiation Treatment plus SHR1210 for High-risk locally advanced Rectal Cancer, Meanwhile, screening effective Biomarker base on neoantigen.

In this study, patients with high-risk rectal cancer will receive 3 cycles induction CapeOX and SHR-1210, intensity modulated radiotherapy with concurrent capecitabine and 2 cycles consolidation CapeOX and total mesorectal excision.

This study is designed to recruit 25 patients in all.

Total Neoadjuvant Treatment Plus SHR1210 for High-risk Rectal Cancer and Biomarker Screening Base on Neoantigen

A Phase II Study of Total Neoadjuvant Chmoradiation Treatment Plus SHR1210 for High-risk Locally Advanced Rectal Cancer and Biomarker Screening Base on Neoantigen

The number of patients with pCR divided by the total number of patients

Category and grade of adverse event during neoadjuvant chemotherapy

Use neoantigen model to find biomarkers related to the effect of TNT+SHR1210 for patients with rectal cancer; compare and analyze the differences in TCR repertoire changes in peripheral blood.

The 3-year DFS will be defined as the percentage of patients alive without local recurrence or distant metastasis of disease at 3 years measured from the date of the administration of treatment.

Rate of patients who had surgical complications during the perioperative period

Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.

Peking University Cancer Hospital & Institute

Chief, Unit III & Ostomy Service, Gastrointestinal Cancer center

Skin and Connective Tissue Diseases

Breast Neoplasms

Hypoglycemic Agents

Antirheumatic Agents

Anti-Infective Agents

Metformin

Docetaxel

Cyclophosphamide

Epirubicin

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Docetaxel: 75mg/m2, d1, q3w\*6 Epirubicin: 75mg/m2, d1, q3w\*6 Cyclophosphamide: 500mg/m2, d1, q3w\*6 Metformin: 500mg tid, orally (500mg daily in first cycle)

Docetaxel: 75mg/m2, d1, q3w\*6 Epirubicin: 75mg/m2, d1, q3w\*6 Cyclophosphamide: 500mg/m2, d1, q3w\*6

Metformin: 500mg tid, orally (500mg daily in first cycle) on day 1 to day 21 of each 21 day cycle

75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; 6 cycles.

500 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; 6 cycles.

cyclophosphomide

Kunwei Shen, Dr.

To evaluate docetaxel, epirubicin and cyclophosphomide (TEC) with TEC plus metformin in neoadjuvant treatment of breast cancer patients. The aim is to evaluate whether metformin can increase the pCR rate combination with TEC regimen in neoadjuvant setting.

Neoadjuvant therapy is the standard treatment for locally advanced breast cancer and has adopted in early breast cancer treatment. A meta-analysis showed no difference between neoadjuvant therapy and adjuvant therapy in terms of survival and overall disease progression. Therefore, neoadjuvant treatment can be offered as a standard treatment and as an alternative to adjuvant treatment to all patients who are expected to be candidates for adjuvant systemic chemotherapy. Patients achieved pCR after treatment have superior outcome.

The taxanes were introduced into clinical practice in the early 1990s, and recent meta-analysis showed that compared with anthracycline-containing chemotherapy, taxanes-containing regimens significantly reduced the annual breast cancer recurrences and deaths. Right now, TAC regimen has widely accepted as adjuvant or neoadjuvant chemotherapy regimens in breast cancer treatment.

Metformin, an inexpensive oral agent commonly used to treat type 2 diabetes, has been garnering increasing attention as a potential anti-cancer agent. In neoadjuvant treatment of breast cancer, a retrospective clinical study from MDACC reported a significantly increased pCR rates to standard neoadjuvant chemotherapy in diabetic breast cancer patients who were receiving metformin (24% pCR) compared to diabetics not receiving metformin (8% pCR), with intermediate rates in non-diabetics who did not receive metformin (16% pCR), indicating metformin may increase pCR rate with neoadjuvant chemotherapy.

Base on these data, we initiate a prospective study to evaluate docetaxel, epirubicin and cyclophosphomide (TEC) with TEC plus metformin in neoadjuvant treatment of breast cancer patients. Our aim is to evaluate whether metformin can increase the pCR rate combination with TEC regimen in neoadjuvant setting.

NeoMET Study in Neoadjuvant Treatment of Breast Cancer

Neoadjuvant Treatment of TEC Versus TEC Plus Metformin in Breast Cancer：A Prospective, Randomized Trial

To compare pathologic complete response (pCR) rate to neoadjuvant chemotherapy between Docetaxel, Epirubicin and Cyclophosphamide (TEC) arm and TEC plus Metformin arm in breast cancer.

Definition of pCR is no invasive tumor in primary breast and axillary lymph node.

To compare the clinical response rate between Docetaxel, Epirubicin and Cyclophosphamide (TEC) arm and TEC plus Metformin arm in breast cancer neoadjuvant treatment.

To compare the tolerability and side effects of neoadjuvant chemotherapy between Docetaxel, Epirubicin and Cyclophosphamide (TEC) arm and TEC plus Metformin arm in breast cancer treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Total Neoadjuvant Treatment Plus SHR1210 for High-risk Rectal Cancer and Biomarker Screening Base on Neoantigen	NCT04340401	Rectal Cancer	SHR-1210 Oxaliplatin Capecitabine Intensity modul... Total mesorecta...	18 Years - 70 Years	Peking University Cancer Hospital & Institute
Total Neoadjuvant Treatment Plus SHR1210 for High-risk Rectal Cancer and Biomarker Screening Base on Neoantigen	NCT04340401	Rectal Cancer	SHR-1210 Oxaliplatin Capecitabine Intensity modul... Total mesorecta...	18 Years - 70 Years	Peking University Cancer Hospital & Institute
Total Neoadjuvant Treatment Plus SHR1210 for High-risk Rectal Cancer and Biomarker Screening Base on Neoantigen	NCT04340401	Rectal Cancer	SHR-1210 Oxaliplatin Capecitabine Intensity modul... Total mesorecta...	18 Years - 70 Years	Peking University Cancer Hospital & Institute
NeoMET Study in Neoadjuvant Treatment of Breast Cancer	NCT01929811	pCR Rate BCT Rate Safety	Metformin Docetaxel Epirubicin cyclophosphomid...	18 Years - 70 Years	Shanghai Jiao Tong University School of Medicine

Spots Global Cancer Trial Database for pcr rate

Every month we try and update this database with for pcr rate cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for pcr rate

Every month we try and update this database with for pcr rate 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 pcr rate 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.