Antineoplastic Agents

All Drugs and Chemicals

Herbal and Botanical

Capecitabine

Antimetabolites

Cola

The control group was treated with capecitabine at a conventional dose: 1,250 mg/m2 orally twice daily (once in the morning and once in the evening; equivalent to a total daily dose of 2,500 mg/m2). Treatment was given for 2 weeks, followed by a 1 week of discontinuation, with each cycle lasting 3 weeks, and there were a total of 4 cycles. Administration: Swallow the tablet whole with water 30 min after breakfast and dinner every day.

The medium-dose group was treated with medium-dose capecitabine: 1,000 mg/m2 orally twice daily (once in the morning and once in the evening; equivalent to a total daily dose of 2,000 mg/m2). Treatment was given for 2 weeks, followed by a 1 week of discontinuation, with each cycle lasting 3 weeks, and there were a total of 4 cycles. Administration: Swallow the tablet whole with water 30 min after breakfast and dinner every day.

The low-dose group was treated with low-dose capecitabine: 750 mg/m2 orally twice daily (once in the morning and once in the evening; equivalent to a total daily dose of 1,500 mg/m2). Treatment was given for 3 weeks per cycle, with each cycle lasting 3 weeks, and there were a total of 4 cycles. Administration: Swallow the tablet whole with water 30 min after breakfast and dinner every day.

The control group was treated with 2,500 mg/m2 capecitabine, with 2,000 mg/m2 capecitabine for the medium-dose group and 1,500 mg/m2 capecitabine for the low-dose group.

capecitabine

To observe the clinical efficacy and adverse reactions of capecitabine in the treatment of advanced colon cancer. A total of 150 patients with advanced colon cancer were selected by convenience sampling and then were divided into the control group (n = 50), the medium-dose group (n = 50), and the low-dose group (n = 50) using a random number table.Different administration regimens of capecitabine were given, and the treatment course was appropriately extended. The therapeutic effect and incidence of adverse reactions were observed.

To observe the clinical efficacy and adverse reactions of capecitabine in the treatment of advanced colon cancer. A total of 150 patients with advanced colon cancer were selected by convenience sampling and then were divided into the control group (n = 50), the medium-dose group (n = 50), and the low-dose group (n = 50) using a random number table.The control group was treated with 2,500 mg/m2 capecitabine, with 2,000 mg/m2 capecitabine for the medium-dose group and 1,500 mg/m2 capecitabine for the low-dose group. Afterward, the response rate, quality of life, and adverse reactions of the three groups were collected for comparison.

The Therapeutic Effect of Different Doses of Capecitabine

Clinical Effect Analysis of Different Regimens of Capecitabine in the Treatment of Patients With Advanced Colon Cancer

Overall response rate (RR%): complete response (CR) + partial response (PR)/total number of cases×100%.

Disease control rate (DR)% = (CR+PR+SD)/total number of cases×100%.

Quality of life was scored using the QLQ-C30 (Quality of Life Questionnaire-core30).QLQ-C30 is composed of one global quality of life scale and five functional scales, which include physical function, role function, emotional function, cognitive function, and social function. Scoring criteria: After the scores of each part of the scale were converted to standardized scores, the scores ranged from 0 to 100, and the higher the score of the scale, the better the overall quality of life and functional status.

Adverse reactions include hand-foot syndrome, stomatitis, leukopenia, nausea and vomiting, bone marrow suppression, and pigmentation. Incidence of adverse reactions%=number of adverse reaction cases/total number of cases × 100%

Jingjiang People's Hospital

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

Bendamustine Hydrochloride

Brentuximab Vedotin

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Immunotoxins

Immunoconjugates

Immunologic Factors

Adcetris® (BV) : 1.2 mg/kg intravenously every 3 weeks Levact® (Be): 90 mg/m2/day intravenously for 2 days every 3 weeks. Up to 6 cycles

Association of Adcetris (1.2 mg/kg intravenously every 3 weeks) with Levact (90 mg/m2/day intravenously for 2 days every 3 weeks) during at least 6 cycles.

Adcetris-Levact

Treatment outcome with ABVD in elderly patients remains inferior to adults. Moreover, Bleomycin-induced lung toxicity in the elderly has been reported as high as 46%. For these reasons, questions arise whether ABVD could be still considered the standard treatment in HL patients aged \> than 60. Regimens containing other alkylators such as CHOP proved even superior to ABVD, with a 3-y PFS of 67%. Frontline treatment of advanced-stage HL with Brentuximab Vedotin (BV) in association with AVD (Doxorubicin, Vinblastine, Dacarbazine) proved very active in a pioneer study, reporting the preliminary results of a phase 1 multicentre trial, in which the percentage of patients achieving CR was as high as 92%. For all these reason the investigators decided to test the association of an alkylator with an innovative mechanism of action and a very safe toxicity profile in the elderly such as Bendamustine (Be) with BV in untreated elderly HL patients.

The combination of BV and Be, investigated in this study, might represent an innovative treatment alternative for HL patients older than 60 years of age, especially for those of them in whom ABVD chemotherapy, the current standard front-line treatment, is not suitable. However, even when ABVD is given as upfront treatment for elderly HL patients, it is associated with substantial dose reduction, treatment delay, toxicity, and treatment-related mortality, with treatment outcomes remaining much inferior to those obtained in younger patients. This drug association is expected to be safe, well-tolerated and to demonstrate higher efficiency compared with ABVD. In this setting, it is expected that this therapy could be offered to the large majority of elderly patients with a full treatment completion reached in up to 80% of these patients.

Thus, the aim of this study will be to assess safety and efficacy of the above association.

Hodgkin Lymphoma Treatment With Adcetris and Levact in the Old Patient

A Phase 1/2 Clinical Trial to Assess Safety and Efficacy of a New Treatment for Hodgkin Lymphoma's Disease Combining Adcetris® and Levact® in Old Patients

To evaluate the tolerability and toxicity of Adcetris-Levact (BV-Be) association.

To evaluate the efficacy in terms of Response Rate after treatment completion of Adcetris-Levact (BV-Be) association.

* To evaluate the efficacy in terms of:
* Progression Free Survival at 3 years
* Event Free Survival at 3 years
* Overall Survival at 3 years

• To evaluate the efficacy in terms of Complete Response Rate after two cycles of Adcetris-Levact (BV-Be) association

Millennium: The Takeda Oncology Company

Centre Antoine Lacassagne

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Vaccines

tumor neoantigen primed DC vaccines are administrated, 2-week interval, totally 5 times

DC vaccine

Zhen-Yu Ding, Prof

The study is aimed to the test the efficacy and safety of neoantigen-primed dendritic cell (DC) cell vaccine therapy for refractory non-small cell lung cancer.

Patients with pathological confirmed non-small cell lung cancer with no standard treatment are enrolled. The patients fails in previous at least 2 lines of chemotherapy and 1 line of targeted therapy where applicable. This is a prospective exploratory trial. Patients' rebiopsy tumor tissues are subsequent to whole exosome sequencing and possible neoantigens are identified. DC is in vitro primed with synthesized peptides. Both adverse events and responses are recorded.

Personalized DC Vaccine for Lung Cancer

Neoantigen-primed DC Vaccine Therapy for Refractory Non-small Cell Lung Cancer

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Number of participants with objective responses as assayed by RECIST 1.1

Sichuan University

Professor

Digestive System Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Tumor antigen-sensitized vaccine is administrated, 1-week interval, totally 2 times.

2-week later, Neo-antigen DC vaccine is administrated, 2-week interval, totally 5 times.

Tumor antigen-sensitized DC vaccine

The aim of this single center, single arm and prospective study is to explore the safety and efficacy of tumor antigen-sensitized DC vaccine in postoperative adjuvant treatment of esophageal cancer.

Tumor Antigen-sensitized DC Vaccine as an Adjuvant Therapy for Esophagus Cancer

Research on the Transformation of Postoperative Adjuvant Therapy of Tumor Antigen-sensitized DC Vaccine Applied to Esophagus Cancer

Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0

Number of participants with Disease-free Survival as assessed by RECIST1.1

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Fluorouracil

Oxaliplatin

146 patients with gastric cancer were randomly divided into a treatment group of 73 cases and a control group of 73 cases. The treatment group received combination chemotherapy with Modified Banxia Xiexin Decoction

The control group received combination chemotherapy with Placebo granules.

The treatment group#Modified Banxia Xiexin Decoction group#was given Modified Banxia Xiexin Decoction, 2 bags each time, 2 times a day, and 1 hour after meals. The control group(chemotherapy group)#Chemotherapy regimen was based on the Chinese Clinical Oncology Association Guidelines for the Diagnosis and Treatment of Gastric Cancer (2018), including oxaliplatin +5-FU/CF, SOX regimen, XELOX regimen, and S-1 monotherapy regimen.

Modified Banxia Xiexin Decoction

combination chemotherapy with Placebo granules

Mingyu Sun, doctor

Research purpose To elucidate the effect mechanism and clinical effective of Modified Banxia Xiexin Decoction in the prevention and treatment of gastric cancer. From genes related to cell differentiation, proliferation, apoptosis, tumor invasion and metastasis, genes related to immune inflammation and immune escape and other possible aspects to elucidate the effective and mechanism of Modified Banxia Xiexin Decoction's treatment on gastric cancer

Modified Banxia Xiexin Decoction treatment and mechanism on Gastric Cancer. Main Responsibility Person: Mingyu Sun research center#Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Trial Objective#Observe the clinical efficacy and mechanism of Modified Banxia Xiexin Decoction in the treatment gastric cancer Therapeutic Schedule#In this study, 146patients with gastric cancer who received chemotherapy in the Department of Gastrointestinal Surgery and Oncology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine were recruited and divided into groups according to random number table method, namely, 73 patients in the Modified Banxia Xiexin Decoction combined chemotherapy group and 73 patients in the Placebo granules combined chemotherapy group.Modified Banxia Xiexin Decoction group was treated with 18 weeks of Chinese patent medicine Modified Banxia Xiexin Decoction at the same time of chemotherapy. The Overall survival, Progression-free survival, Solid tumor efficacy, TCM syndrome score, quality of life score, Tumor markers, Immune function and adverse reactions of the two groups before and 18 weeks after treatment were observed and compared. Elucidate the possible mechanism of action of Modified Banxia Xiexin Decoction in the treatment of gastric cancer patients.

Clinical Study of Modified Banxia Xiexin Decoction Treatment on Gastric Cancer

Randomized Clinical Trial:Clinical Study of Modified Banxia Xiexin Decoction Treatment on Gastric Cancer

To observe the effects of treatment group and control group on OS in patients with advanced gastric cancer, and evaluate whether there is statistical difference in OS between the two groups.From date of randomization until the date of death from any cause, whichever came first, assessed up to 18 months.

The time between the first treatment and tumor progression or death.From date of randomization until the date of first documented progression, whichever came first, assessed up to 18 months. To observe the effects of treatment group and control group on PFS in patients with advanced gastric cancer, and evaluate whether there is a statistical difference in PFS between the two groups.

The quality of life score is based on the EuroPean organization for Research and Treatment (EORTC) Quality of Life Scale (QLQ-C30 v3.0), which records changes in quality of life before and after treatment and compares them. Linear transformation of statistical results was performed to obtain standardized scores (0\~100 points), so that scores in various fields could be compared with each other, and the problem of reverse entries could be solved at the same time. The higher the score of symptom field obtained by each subscale, the worse the quality of life condition. The higher the scores in the areas of function and general health, the better the patient's quality of life. Analyze whether there was a statistical difference between the two groups.

According to the scoring criteria of the Guidelines for Clinical Research of New Chinese Medicines (2002), the symptoms of patients after treatment were determined. The improvement of patients' overall symptoms was evaluated by Nimodipine method, and the efficacy index after treatment = (total score before treatment - total score after treatment)/total score before treatment \*100%.

Detect the biomarkers (CA72-4, CEA, CA19-9, CA242, CA50, CA125) of two groups of patients before and after treatment to determine whether there is a statistical difference between the two groups before and after treatment.

T cell subsets of the two groups to determine whether there was a statistical difference between the two groups before and after treatment.

ShuGuang Hospital

Clinical Professor

72 patients with gastric cancer were randomly divided into a treatment group of 36 cases and a control group of 36 cases. The treatment group received combination chemotherapy with Weifuchun tablets, while the control group received monotherapy chemotherapy.

The treatment group#Weifuchun group#was given Weifuchun tablets, 4 tablets each time, 3 times a day, and 1 hour after meals. The control group(chemotherapy group)#Chemotherapy regimen was based on the Chinese Clinical Oncology Association Guidelines for the Diagnosis and Treatment of Gastric Cancer (2018), including oxaliplatin +5-FU/CF, SOX regimen, XELOX regimen, and Ticeo monotherapy regimen.

Weifuchun

Research purpose To elucidate the effect mechanism and clinical effective of weifuchun in the prevention and treatment of gastric cancer. From genes related to cell differentiation, proliferation, apoptosis, tumor invasion and metastasis, genes related to immune inflammation and immune escape and other possible aspects to elucidate the effective and mechanism of weifuchun's treatment on gastric cancer.

Weifuchun Treatment and mechanism on Gastric Cancer. Main Responsibility Person: Mingyu Sun research center#Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Trial Objective#Observe the clinical efficacy and mechanism of Weifuchun in the treatment gastric cancer Therapeutic Schedule#In this study, 72 patients with gastric cancer who received chemotherapy in the Department of Gastrointestinal Surgery and Oncology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine were recruited and divided into groups according to random number table method, namely, 36 patients in the Weifichun combined chemotherapy group and 36 patients in the chemotherapy group alone. Weichun group was treated with 24 weeks of Chinese patent medicine Weichun tablet at the same time of chemotherapy. The physical status score, TCM syndrome score, quality of life score, bone marrow suppression and tumor index of the two groups before and 24 weeks after treatment were observed and compared.Fecal samples of the above patients before and after the entry and exit groups were collected, screened and submitted for examination. Finally, 15 cases were submitted for examination in the Weifichun combined chemotherapy group and chemotherapy group alone, and 10 cases were submitted for examination in the healthy volunteers. Miseq platform was used to conduct high-throughput sequencing and analysis of 16S ribosomal RNA of intestinal flora, fecal quality assessment of intestinal flora tested was conducted, α diversity and β diversity were analyzed, and the flora structure, including the level of taxonomy, family, genus, etc., were compared to analyze the differences in each group, and elucidate the possible mechanism of action of Weichun in the treatment of gastric cancer patients.

Clinical Study of Weifuchun Treatment on Gastric Cancer

Randomized Clinical Trial:Clinical Study of Weifuchun Treatment on Gastric Cancer

To observe the effects of treatment group and control group on OS in patients with advanced gastric cancer, and evaluate whether there is statistical difference in OS between the two groups.From date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months.

The time between the first treatment and tumor progression or death.From date of randomization until the date of first documented progression, whichever came first, assessed up to 24 months. To observe the effects of treatment group and control group on PFS in patients with advanced gastric cancer, and evaluate whether there is a statistical difference in PFS between the two groups.

T cell subsets of the two groups were detected before and after treatment to determine whether there was a statistical difference between the two groups before and after treatment.

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gemcitabine

Tislelizumab

(1)8 cycles of Gemcitabine +capecitabine (Gemcitabine d1,8 ,Capecitabine d1-14 q3w）；（2） two 200 mg intravenous dose of tislelizumab (d1,q3w)（3）five intravenous doses of neoantigen vaccines given as priming doses(d1,8,22,36,50）and two booster dose(d80,d110)

Gemcitabine +capecitabine, tislelizumab, neoantigen vaccines

Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy

zhong Wu, MD

Zhong Wu, MD

Zhong Wu

The aim of this single center, single arm and prospective study is to explore the safety and efficacy of Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in postoperative adjuvant treatment of Pancreatic Cancer

Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy as an Adjuvant Therapy for Pancreatic Cancer

Adjuvant Therapy of Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in Patients With Resected Pancreatic Cancer

defined recurrence as new lesions on the basis of response evaluation criteria in solid tumours (v.1.1), and RFS from either the date of surgery (RFS) or from the date of the last neoantigen vaccine priming dose to the date of recurrence or death, whichever occurred first.

Defined by treatment-related adverse events as assessed by CTCAE v4.0

defined OS from the date of surgery to the date of death.

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Melanoma

Urinary Bladder Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Neuroendocrine Tumor

Neuroepithelioma

Tumor antigen-sensitized vaccine is administrated, 1- week interval, totally 2 times.

Then, Neo-antigen DC vaccine and their sensitized T cells are administrated, 2-week interval, totally 5 times.

Tumor antigen-sensitized DC vaccine and their sensitized T cells subcutaneous administration

Ji-Yan Liu, Prof

Ji-Yan Liu

This single center, single arm and prospective study aimed to establish gene mutation database and select the neoantigens in patients with advanced malignant melanoma, bladder cancer and colorectal cancer. Then, we intended to explore the safety and efficacy of individual tumor antigen-sensitized DC vaccine and their sensitized T cells in these solid cancers.

Personalized Immune Cell Therapy Targeting Neoantigen of Malignant Solid Tumors

Carcinoma, Hepatocellular

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Liver Neoplasms

Liver Diseases

tumor neoantigen primed DC vaccines are administrated, 2-3 week interval, totally 3-5 times

DC vaccine subcutaneous administration

Qiu Li

Qiu Li, PhD

The study is aimed to the test efficacy and safety of neoantigen-primed dendritic cell (DC) cell vaccine therapy for postoperative locally advanced gastric cancer, hepatocellular carcinoma, lung cancer and colorectal cancer, and to explore the biomarkers related to efficacy and adverse event.

Postoperative patients with pathological confirmed locally advanced gastric cancer, hepatocellular carcinoma, non-small cell lung cancer and colorectal cancer with standard adjuvant treatment are enrolled. This is a prospective exploratory trial. Patients' tumor tissues are subsequent to whole exosome sequencing and possible neoantigens are identified. DC is in vitro primed with synthesized peptides. Both adverse events and responses are recorded.

Personalized DC Vaccine for Postoperative Cancer

Adjuvant Treatment in Cancer Patients With Neoantigen-primed DC Vaccine : a Single-arm, Open-label, Prospective Clinical Trial

Defined as the time from the surgery to the first documented disease recurrence or death (by any cause), whichever occurs first

Defined by the time between the date of randomization and the date of death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Therapeutic Effect of Different Doses of Capecitabine	NCT06246461	Capecitabine	capecitabine	40 Years - 69 Years	Jingjiang People's Hospital
Hodgkin Lymphoma Treatment With Adcetris and Levact in the Old Patient	NCT02467946	Clinical Effica... Safety	Adcetris-Levact	60 Years - 80 Years	Centre Antoine Lacassagne
Personalized DC Vaccine for Lung Cancer	NCT02956551	Carcinoma, Non-...	DC vaccine	18 Years - 90 Years	Sichuan University
Tumor Antigen-sensitized DC Vaccine as an Adjuvant Therapy for Esophagus Cancer	NCT05023928	Carcinoma Esophagus Cance...	Tumor antigen-s...	18 Years - 75 Years	Sichuan University
Clinical Study of Modified Banxia Xiexin Decoction Treatment on Gastric Cancer	NCT05908838	Gastric Cancer ...	Modified Banxia... combination che...	17 Years - 75 Years	ShuGuang Hospital
Clinical Study of Weifuchun Treatment on Gastric Cancer	NCT05888675	Gastric Cancer ...	Weifuchun	18 Years - 70 Years	ShuGuang Hospital
Clinical Study of Modified Banxia Xiexin Decoction Treatment on Gastric Cancer	NCT05908838	Gastric Cancer ...	Modified Banxia... combination che...	17 Years - 75 Years	ShuGuang Hospital
The Therapeutic Effect of Different Doses of Capecitabine	NCT06246461	Capecitabine	capecitabine	40 Years - 69 Years	Jingjiang People's Hospital
Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy as an Adjuvant Therapy for Pancreatic Cancer	NCT06344156	Pancreatic Canc... Adjuvant Therap...	Neoantigen Vacc...	18 Years - 75 Years	Sichuan University
Personalized Immune Cell Therapy Targeting Neoantigen of Malignant Solid Tumors	NCT05235607	Carcinoma Melanoma Bladder Cancer Colorectal Canc...	Tumor antigen-s...	18 Years - 75 Years	Sichuan University
Personalized DC Vaccine for Postoperative Cancer	NCT04147078	Gastric Cancer Hepatocellular ... Non-Small-Cell ... Colon Rectal Ca...	DC vaccine subc...	18 Years - 100 Years	Sichuan University
Clinical Study of Weifuchun Treatment on Gastric Cancer	NCT05888675	Gastric Cancer ...	Weifuchun	18 Years - 70 Years	ShuGuang Hospital

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