Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Vaccines

Capecitabine

Immunomodulating Agents

Antimetabolites

Patients with advanced breast cancer accept capecitabine monotherapy.

Drug: Capecitabine

Biological/Vaccine: DC-CIK DC-CIK immunotherapy combined with capecitabine are used to treat advanced breast cancer.

Drug: Capecitabine

DC-CIK cells are used to treat advanced breast cancer with capecitabine.

DC-CIK Immunotherapy

All patients receive capecitabine monotherapy (2500 mg/m2 twice daily) for 2 weeks followed by a 1-week rest period.And the treatment is repeated every 3 weeks.

Capecitabine Monotherapy

The prognosis of advanced breast cancer does not improve much recently although varies of adjuvant drugs have been tried.Dendritic cells co-cultured with cytokine-induced killer cells(DC-CIK) immunotherapy has been proved to improve survival in several cancers, but its role in advanced breast cancer stains unclear. The purpose of this study is to evaluate the efficacy and safety of DC-CIK immunotherapy combined with capecitabine versus capecitabine monotherapy for the treatment of advanced breast cancer.

1.400 patients with advanced breast cancer should be definitively diagnosis based on histopathology, according to the 7th American Joint Committee on Cancer(AJCC) Cancer Staging Manual.

2.All patients will be randomly divided into group A（DC-CIK immunotherapy combined with capecitabine ) or group B（capecitabine monotherapy).

3.Patients in group A will receive 4 cycles of DC-CIK treatment (every 1 year) and capecitabine(continuous).Patients in group B will receive only capecitabine monotherapy(continuous) .

4.The response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines.

Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer

Randomized Controlled Trial Comparing Dendritic Cells Co-cultured With Cytokine-induced Killer Cells Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer

The side effect was evaluated according to WHO standards, including diarrhea, nausea, vomiting, hand-foot syndrome and neutropenia.

complete response(CR),partial response(PR),stable disease(SD)and progressive disease(PD).

The First People's Hospital of Changzhou

Digestive System Diseases

Rare Diseases

Stomach Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Stomach Cancer

Capecitabine is administered within 6 weeks after resection and after adequate recovery. To reduce the side effects and improve patient compliance, the administered dose is half of the recommendation: 625 mg/m2, bis in die (BID) (1250 mg/m2 per day). A 2-week therapy is followed by a 1-week pause, and a cycle includes 3 weeks. A total of 8 cycles is planned for each patient.

Capecitabine monotherapy

A-Man Xu, MD

Gastric cancer (GC) is one of the most common and lethal malignancies in Asia. For early (stage T1) GC, it has been found by analyzing surgical specimens that \~5% of cancers have lymph node metastasis. For patients with stage T2-3N0M0 GCs, there is a considerable probability of micro-metastasis. While the US National Comprehensive Cancer Network (NCCN), the Japanese Gastric Cancer Association (JGCA), and the European Society for Medical Oncology (ESMO) guidelines recommend adjuvant therapy for most patients with resected \>T1N0 GCs, the recommendations vary regarding postsurgical treatment for patients with stage T1N+M0 or T2-3N0M0 disease. The JGCA guidelines do not recommend postsurgical chemotherapy for this patient population, while the ESMO support the adjuvant treatment. The NCCN has not offered a definitive recommendation on this issue. Through careful literature search, there is not yet randomized report on whether postsurgical chemotherapy benefits survival for patients with resected T1N+M0 or T2-3N0M0 GC. The first-line chemotherapy regimen for GC is fluorouracil plus platinum. Among fluorouracil, platinum is especially favored due to its less frequent and less severe adverse effects. This large multicenter phase III randomized controlled trial is led by Department of Gastrointestinal Surgery, The First Affiliated Hospital of Anhui Medical University, and carried out in multiple Chinese centers, aiming to compare the safety and efficacy of capecitabine monotherapy versus no therapy in the adjuvant setting for patients with stage T1N+M0 or T2-3N0M0 GC undergoing R0 Resection.

Capecitabine or Observation for Patients With pT1N+M0 or pT2-3N0M0 Gastric Adenocarcinoma Undergoing R0 Resection

Capecitabine or Observation for Patients With pT1N+M0 or pT2-3N0M0 Gastric Adenocarcinoma Undergoing R0 Resection (CAPOGA): A Large Multicenter Phase III Randomized Controlled Trial

The time interval from randomization to local recurrence/distant metastasis, death, or end of follow-up whichever occurs first.

The time interval from randomization to death from any cause or end of follow-up whichever occurs first.

Incidence of Treatment-Emergent/Drug-Associated Adverse Events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events

Health-related quality of life as assessed by European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-Core 30. Except for the last 2 questions, for the first 28 questions higher values represent a worse outcome.

The First Affiliated Hospital of Anhui Medical University

Professor, Chief Surgeon, Department Head

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Oxaliplatin

All rectal patients in this group will receive standard surgical resection.

Starting from the first day of radiotherapy (set as day 0), the patient received a total of 4 courses of XELOX chemotherapy on days -42, -21, 42, and 63, including oxaliplatin 130 mg/m2, intravenous administration, d1, repeat every 3 weeks; and capecitabine 1000mg/m2, twice daily, d1-d14, repeat every 3 weeks.

XELOX

During radiotherapy (Monday to Friday), capecitabine was administered at 1650 mg/m2/d, twice a day.

The TV is expanded by 6-7mm to form PTV1, and the CTV is expanded by 6-7mm to form PTV2. The dose of PTV1 was 50Gy/25 times/35 days, and the dose of PTV2 was 45Gy/25 times/35 days, 5 times/week for a total of 5 weeks.

Radiation

Zhenhai Lu, Prof

Jianhong Peng, M.D

Jianhong Peng, Doctor

Zhifan Zeng, M.D

Xiaojun Wu, M.D

Junzhong Lin, M.D

Rongxin Zhang, M.D

Weiwei Xiao, M.D

Yujing Fang, Ph.D

Fulong Wang, M.D

Yuan Li, M.D

Qingjian Ou, M.D

Weili Zhang, M.D

Jiali Chen, M.D

In the treatment of locally advanced rectal cancer, the short-term and long-term efficacy of the traditional sandwich regimen has not reached satisfactory efficacy. For this reason, the concept of reducing the dose of postoperative chemotherapy or directly moving forward the full amount of postoperative chemotherapy was proposed, which is called total neoadjuvant therapy (TNT). However, TNT also includes the high toxicity of oxaliplatin in the whole process and the long time interval between the end of radiotherapy and the operation, which leads to fibrosis of the surrounding tissue, which increases the difficulty of surgical resection and makes it difficult to ensure good surgical specimen quality. In addition to this, there are issues that may increase the risk of potential disease progression in patients with poor treatment withdrawal. Therefore, appropriately reducing the intensity of chemotherapy and controlling the total duration of preoperative neoadjuvant therapy during radiotherapy is expected to alleviate the side effects of neoadjuvant therapy. Here, the investigators synthesized the characteristics of TNT and sandwich regimens and proposed a XELOX regimen and capecitabine alternate administration combined with preoperative intensity modulated radiation therapy.

Modified Sandwich Therapeutic Regimen for Locally Advanced Rectal Cancer

Single Arm and Phase II Clinical Trial of a Sandwich Regimen as XELOX Regimen and Capecitabine Alternate Administration Combined With Preoperative Intensity Modulated Radiation Therapy for pMMR Locally Advanced Rectal Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer	NCT02491697	Breast Cancer	DC-CIK Immunoth... Capecitabine Mo...	18 Years - 75 Years	The First People's Hospital of Changzhou
Capecitabine or Observation for Patients With pT1N+M0 or pT2-3N0M0 Gastric Adenocarcinoma Undergoing R0 Resection	NCT03817268	Gastric Cancer	Capecitabine mo...	18 Years - 70 Years	The First Affiliated Hospital of Anhui Medical University
Modified Sandwich Therapeutic Regimen for Locally Advanced Rectal Cancer	NCT05228431	Advanced Rectal...	XELOX Capecitabine mo... Radiation	18 Years - 75 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for capecitabine monotherapy