Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Tegafur

Antimetabolites

All patients will receive gimatecan (0.8mg/m2, on days 1 to 5, PO, every 4 weeks) until progressive disease (PD).

All patients will receive tegafur, gimeracil and oteracil potassium (40-60mg, twice daily, on days 1 to 14 , PO, every 3 weeks) or gemcitabine (1000mg/m2, on days 1、8, IV, every 3 weeks) until progressive disease (PD).

Patients will receive gimatecan orally at 0.8mg/m2 on day 1-5 every 4 weeks.

Gimatecan

Patients will receive tegafur, gimeracil and oteracil potassium orally at 40 or 60mg twice daily on days 1 to 14 every 3 weeks.

tegafur, gimeracil and oteracil potassium

Patients will receive gemcitabine IV at 1000mg/m2 on days 1、8 every 3 weeks.

gemcitabine

WANG LIWEI, MD

This phase II clinical trial studies the safety and effect of as second-line treatmen in local advanced or metastatic pancreatic cancer. The Gimatecan will be given every four weeks.

A Phase II Study of Gimatecan (ST1481) in Locally Advanced or Metastatic Pancreatic Cancer

Gimatecan (ST1481) as Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer: an Open-label, Randomized, Controlled Phase II Study

The 2-year progression free survival of the whole group.

The 2-year overall survival of the whole group.

Percentage of patients with objective response assessed by best overall.

The duration is measured from the first documented response (CR or PR, whichever is first recorded) until the first assessment of Progressive Disease (PD).

Percentage of patients with disease control as assessed by best overall.

Change from baseline assessed according to the quality of life questionnaire C30.

Lee's Pharmaceutical Limited

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Capecitabine

Oxaliplatin

The participants volunteering to take Huaier granule will be assigned to the Huaier group.

The participants volunteering to take SOX or XELOX will be assigned to the control group.

Huaier granule, oral administration, 20g each time, 3 times a day. Continuous medication until the end of the study, intolerable toxicity, withdrawal from the study for any reason or death, whichever occurs first; or after researcher's judgment, participants will no longer benefit from the treatment. After disease progression, whether to continue the medication or not should be determined by the researcher and participant together. Participants will start taking Huaier granule 10 days after surgery.

Huaier granule

Participants will receive intravenous infusion of 130 mg/m² oxaliplatin on the first day of treatment cycle.

Participants will receive oral Tegafur, Gimeracil and Oteracil Potassium (40 mg/m², twice a day) for 2 weeks, followed by 1 week of rest.

Tegafur, Gimeracil and Oteracil Potassium

Participants will receive oral Capecitabine (1000 mg/m², twice a day) for 2 weeks, followed by 1 week of rest.

Kaixiong Tao, PhD

Yuping Yin, PhD

Yanbing Zhou

This is a prospective, multi-center, observational study. The purpose of this study is to evaluate the efficacy and safety of Huaier Granule versus standard chemotherapy regimens in the postoperative adjuvant treatment of resectable stage II-III gastric cancer.

Gastric cancer (GC) is the second most frequently diagnosed cancer and the second leading cause of cancer related deaths in China. China has a higher mortality/incidence ratio (0.845). For stage II-III GC patients, the current standard treatment is D2 gastrectomy followed by adjuvant chemotherapy. Studies showed the 5-year survival rate of early GC is nearly 95%, while the 1-year recurrence and metastasis rate after surgery is about 50%, and the rate of 2-year is as high as 70%.

Although adjuvant chemotherapy can prevent recurrence, it is inevitable to the appearance of toxic and side effects, which seriously affect the prognosis and quality of life.

Traditional Chinese medicine plays a unique role in enhancement of immune function, detoxification, and synergism of chemoradiotherapy. Huaier granule is an extract from a medicinal fungus. Previous studies have shown that Huaier granule can inhibit the proliferation, angiogenesis, metastasis and invasion of cancer cells, and can reverse the resistance of targeted drugs. Previous studies demonstrated Huaier granule is benefit to resistance to recurrence and metastasis, prolongation of patients' survival, and improvement of quality of life.

In this study, about 20 research centers will participate. Total of 828 participants will be divided into two groups (the Huaier group and the control group) at a ratio of 1:1. The Huaier group will receive Huaier granule as postoperative adjuvant therapy, and the control group will receive SOX or XELOX. The planned length of patient recruitment enrolment will be 2 years and the total length of visits be 3 years. After enrollment, participants will be visited every 3 months (window period ± 14 days) until the end of the study or until the patient withdraws from the study for any reason or dies.

Effect and Safety of Adjuvant Huaier Granule Versus Standard Chemotherapy Regimens in Gastric Cancer Patients

Effect and Safety of Adjuvant Huaier Granule Versus Standard Chemotherapy Regimens in Resectable Stage II-III Gastric Cancer Patients: a Prospective, Multi-center, and Observational Study

The proportion of patients who does not have recurrence of primary cancer, new gastric cancer, distant metastases (assessed by each investigator), or death from any cause within 3 years after receiving surgery.

The proportion of patients who do not have recurrence of primary cancer, new gastric cancer, distant metastases (assessed by each investigator), or death from any cause within 1/2 years after receiving surgery.

The proportion of patients who will be alive within 1/2/3 years after receiving surgery.

The proportion of patients who do not have local recurrence or regional lymph node metastasis from an cause within 1/2/3 years after receiving surgery.

The proportion of patients who do not have distant metastasis from an cause within 1/2/3 years after receiving surgery.

The patients will evaluated by the Short-Form 36 (SF-36) Health Survey (Chinese version), which is a 36-item questionnaire measures health on 8 multi-item dimensions. Scores are computed for each dimension by adding the recorded item responses together and transforming the results onto a scale from 0 (worst health on scale) to 100 (best health on scale).

The incidence of adverse events and serious adverse events (referring to CTCAE 5.0 ) will be analyzed.

The incidence of ADR, SADR and SUSAR (referring to CTCAE 5.0 ) will be analyzed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase II Study of Gimatecan (ST1481) in Locally Advanced or Metastatic Pancreatic Cancer	NCT04571489	Pancreatic Canc...	Gimatecan tegafur, gimera... gemcitabine	18 Years -	Lee's Pharmaceutical Limited
A Phase II Study of Gimatecan (ST1481) in Locally Advanced or Metastatic Pancreatic Cancer	NCT04571489	Pancreatic Canc...	Gimatecan tegafur, gimera... gemcitabine	18 Years -	Lee's Pharmaceutical Limited
Effect and Safety of Adjuvant Huaier Granule Versus Standard Chemotherapy Regimens in Gastric Cancer Patients	NCT05498766	Gastric Cancer	Huaier granule Oxaliplatin Tegafur, Gimera... Capecitabine	18 Years - 70 Years	Wuhan Union Hospital, China

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