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Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

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Antimitotic Agents

Gemcitabine monotherapy 1000 mg/m2 weekly

Gemcitabine alone

EndoTAG-1 11 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly

EndoTAG-1 and Gemcitabine

EndoTAG-1 22 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly

EndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly

Matthias Löhr, Prof.

The intention of this trial is to evaluate safety and efficacy of a combination treatment of EndoTAG-1 with Gemcitabine versus Gemcitabine monotherapy.

EndoTAG-1 / Gemcitabine Combination Therapy to Treat Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas

A Controlled, Randomized, Open Label Phase II Trial to Evaluate Safety and Efficacy of a 1st Line Combination Treatment With Weekly Infusions of Gemcitabine and Twice Weekly Administration of Lipid Complexed Paclitaxel (EndoTAG-1) in Three Dose Levels Compared With Gemcitabine Monotherapy in Patients With Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas

MediGene

Susanne Kienzle-Horn / Clinical Trial Manager

Herbal and Botanical

Astragalus

Participants will receive Astragalus in combination with Gemcitabine by intravenous infusion (IV).

Participants will receive IV infusion of 20ml of Astragalus injection (the content of Astragalus crude drug is 2g/ml plus 250ml of normal saline 1 day before chemotherapy, once a day for 21 consecutive days constitute a course of treatment a total of 4 courses of treatment.

Gemcitabine is one of the main chemotherapy drugs used to treat pancreatic cancer.

Participants will receive Neoadjuvant Chemotherapy of Gemcitabine 1000 mg/m2 as a 30- to 40-minute infusion (maximum 40 minutes) administered weekly for 7 weeks followed by a week of rest (8-week cycle; cycle 1 only), followed by cycles of weekly administration for 3 weeks (on days 1, 8, and 15) followed by one week of rest (4-week cycle).

Participants will receive Astragalus combined with Gemcitabine. Astragalus, a traditional Chinese medicine, exhibits promising potential in cancer treatment. Studies suggest its role in regulating immune responses, suppressing tumors, and improving overall treatment outcomes in cancer patients. Astragalus combined with chemotherapeutic drug such as Gemcitabine is a popular complementary and alternative therapy used for cancer patients because it can increase therapeutic effects and decrease side effects. This synergistic approach holds potential for more effective and targeted therapeutic outcomes in pancreatic cancer patients.

Astragalus + Gemcitabine

Gemcitabine is a potent chemotherapy drug widely employed in treating various cancers, including pancreatic cancer. As a nucleoside analog, it disrupts DNA synthesis, impeding cancer cell proliferation. Gemcitabine is administered intravenously and has shown efficacy in alleviating symptoms, improving survival rates, and enhancing the quality of life for patients undergoing cancer treatment.

Wei Zhang, PhD

Mikiyas Amare Getu, PhD

Xianbin Zhang, PhD

This study compare the efficacy of Astragalus combined with Gemcitabine to Gemcitabine alone as neoadjuvant treatment for pancreatic cancer.

Astragalus is a commonly used traditional Chinese medicine in China, which has been widely applied to enhance the immunomodulatory function of the body and suppress the growth of tumors. It was often combined with other herbs to strengthen the body against disease. The effects and mechanisms of Astragalus and Shenqi Fuzheng Injection (the main ingredients are Codonopsis and Astragalus) in the treatment of digestive tract diseases were studied. Investigators found that Astragalus can not only inhibit the growth of pancreatic tumors, but also down regulate the ability of CAFs to secrete βig-h3, thereby inducing CD8+T proliferation and inhibiting the polarization of macrophages into M2 macrophages, thereby enhancing the response of pancreatic tumors to gemcitabine and other treatment options.

Thus, the objective of this study is to compare the impact of combining Astragalus with Gemcitabine versus Gemcitabine alone as neoadjuvant treatment for pancreatic cancer.

Comparing Astragalus Plus Gemcitabine to Gemcitabine Alone as Neoadjuvant Treatment for Pancreatic Cancer Patients

Comparison of Neoadjuvant Treatment for Pancreatic Cancer: Astragalus Combined With Gemcitabine Versus Gemcitabine Alone - A Single-Center, Randomized, Double-Blind Study

Objective response rate (ORR) measures the overall treatment response by assessing the percentage of patients with complete or partial tumor shrinkage after treatment.

Surgical resection rate refers to the percentage of patients who undergo surgical removal (resection) of a tumor or diseased tissue as part of their medical treatment.

Percentage of patients with a 50% decrease in CA19-9 measures the proportion of individuals whose CA19-9 tumor marker levels have reduced by at least 50%, indicating a potential positive response to treatment

Safety and Tolerance of Chemotherapeutic Drugs refers to the assessment of adverse events and side effects associated with chemotherapy, using the Common Terminology Criteria for Adverse Events (CTCAE) scale, which evaluates the safety profile and tolerability of chemotherapy in patients.

From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, up to approximately 3 years.

OS will be calculated as date of death minus date of first dose of study medication plus 1. In the absence of death confirmation, OS will be censored at the date of last study follow-up. Analysis will be performed by Kaplan-Meier method.

R0 resection rate signifies the percentage of surgical procedures in which the entire tumor is successfully removed with no residual cancerous tissue remaining (complete microscopic tumor removal).

Shenzhen University General Hospital

Principal Investigator

Recurrence

Capecitabine

Gemcitabine + Capecitabine

Richard Herrmann, MD

Werner Scheithauer, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if gemcitabine is more effective with or without capecitabine in treating pancreatic cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with or without capecitabine in treating patients who have advanced pancreatic cancer.

OBJECTIVES:

* Compare the overall survival of patients with advanced pancreatic cancer treated with gemcitabine with or without capecitabine.
* Compare the clinical benefit response, objective tumor response, duration of response, and time to progression in patients treated with these regimens.
* Compare the toxicity of these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to metastases (yes vs no), pain (yes vs no), Karnofsky performance status (60-80% vs 90-100%), and participating center. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients initially receive gemcitabine IV over 30 minutes weekly for 7 weeks. After 1 week of rest, patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Treatment then repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, weekly for weeks 2-7, and then before each gemcitabine administration.

Patients are followed every 9 weeks.

PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.

Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer

Gemcitabine Plus Capecitabine Versus Gemcitabine Alone In Advanced Pancreatic Cancer. A Randomized Phase III Trial

To compare survival, efficacy, quality of life and toxicity between the combination therapy (Capecitabine and Gemcitabine) and the monotherapy (Gemcitabine alone) in advanced pancreatic cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
EndoTAG-1 / Gemcitabine Combination Therapy to Treat Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas	NCT00377936	Adenocarcinoma Metastasis Pancreas Neopla...	Gemcitabine alo... EndoTAG-1 and G... EndoTAG-1 and G... EndoTAG-1 and G...	18 Years -	MediGene
Comparing Astragalus Plus Gemcitabine to Gemcitabine Alone as Neoadjuvant Treatment for Pancreatic Cancer Patients	NCT06234072	Pancreatic Canc...	Astragalus + Ge... Gemcitabine alo...	18 Years -	Shenzhen University General Hospital
Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer	NCT00030732	Pancreatic Canc...	Gemcitabine + C... Gemcitabine alo...	18 Years - 120 Years	Swiss Group for Clinical Cancer Research

Spots Global Cancer Trial Database for gemcitabine alone