Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Capecitabine

Trastuzumab

Irinotecan

Leucovorin

Fluorouracil

Oxaliplatin

Antineoplastic Agents, Immunological

Camrelizumab: 200mg, iv, 21d for a treatment cycle Trastuzumab: 8 mg/kg loading dose, followed by 6 mg/kg maintenance, iv, 21d for a treatment cycle Chemotherapy will either be XELOX, mFOLFOX6, FOLFIRI, mXELIRI or mIRIS

Camrelizumab

8 mg/kg loading dose, followed by 6 mg/kg maintenance, iv, 21d for a treatment cycle

Oxaliplatin, 130 mg/m2, iv, d1; Capecitabine, 1000 mg/m2, po, bid, d1-d14; q3w

XELOX regimen

Oxaliplatin, 85 mg/m2, iv, d1; Leucovorin, 400 mg/m2, iv, d1; 5-FU, 400mg/m2, iv, d1 followed by 1200 mg/(m2·d)\*2d, civ, 46h; q2w

mFOLFOX6 regimen

Irinotecan, 180 mg/m2, iv, d1; Leucovorin, 400 mg/m2, iv, d1; 5-FU, 400mg/m2, iv, d1 followed by 1200 mg/(m2·d)\*2d, civ, 46h; q2w

FOLFIRI regimen

Irinotecan, 200 mg/m2, iv, d1; capecitabine, 800 mg/m2, po, bid, d1-d14; q3w

mXELIRI regimen

Irinotecan, 180 mg/m2, iv, d1; Tiggio Capsules (S-1), 40-60 mg/m2, po, bid, d1-d9; q2w

mIRIS regimen

Zhe Zhang, PHD

This study aimed to evaluate the efficacy and safety of camrelizumab combined with trastuzumab and chemotherapy in Patients with HER2-positive advanced colorectal cancer

Camrelizumab Combined With Trastuzumab and Chemotherapy in Patients With HER2-positive Advanced Colorectal Cancer

Camrelizumab Combined With Trastuzumab and Chemotherapy in Patients With HER2-positive Advanced Colorectal Cancer: A Prospective, Single-arm, Open-label Study

The proportion of patients with complete response or partial response according to RECIST v1.1

Time from the initiation of treatment to disease progression or any-cause death

The proportion of patients with complete response, partial response or stable disease according to RECIST v1.1

Time from the initiation of treatment to any-cause death

Time from complete response or partial response to disease progression or any-cause death

Fudan University

Apatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Apatinib Mesylate Tablets 500 mg P.O.d1-21 and XELOX (oxaliplatin 130mg/㎡ i.v. d1, capecitabine 1000mg P.O. d1-d14)

Every 3-week time is a cycle until PD or intolerance of drug toxicity occurs.

Apatinib and XELOX combined treatment group

Shoucheng Ma, Master

Da Zhao, Bachelor

This study makes an observation over the objective response rate of Apatinib and XELOX combination regimen in the first-line treatment of metastatic colorectal cancer. All the participants will receive the treatment of Apatinib and XELOX combination regimen.

XELOX chemotherapy is an effective therapy for metastatic colorectal cancer as first-line treatment.

Apatinib is a small-molecule tyrosine kinase inhibitor (TKI) that highly selectively binds to and strongly inhibits vascular endothelial growth factor receptor 2 (VEGFR-2), with a decrease in VEGF-mediated endothelial cell migration, proliferation, and tumor microvascular density. A phase II trail of Apatinib has been demonstrated that Apatinib is safe to treat the metastatic colorectal cancer and the disease control rate can reach 50%.

Clinical Study of Apatinib and XELOX Combination Regimen to Treat Colorectal Cancer Patients

A Phase II Clinical Trial Study on Apatinib and XELOX Combination Regimen in the First-line Treatment of End-stage Colorectal Cancer Patients

ORR=complete response (CR) + partial response (PR) .And expected ORR is 0.55.

time from randomization to documented progressive disease or death due to any cause, whichever occurs first

Shoucheng Ma

director of cancer center

Rare Diseases

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Amino Acids

Tegafur

Taurine

Taurine + Sintilimab + XELOX or Taurine + Sintilimab + SOX or Taurine + Sintilimab + FOLFOX

Sintilimab + XELOX or Sintilimab + SOX or Sintilimab + FOLFOX

Taurine supplementation in capsules of 1.0 gram of taurine powder. Dosage: 2.0 gram/day. Frequency: 2 time/day.

Sintilimab

Oxaliplatin + S-1 (tegafur/gimeracil/oteracil potassium)

SOX regimen

FOLFOX regimen

Xiaodi Zhao, MD, PhD

Xin Wang, MD, PhD

Jia Yu, MD

Yuanyuan Lu, MD, PhD

This project aims to evaluate the efficacy and safety of oral taurine supplementation combined with PD-1 inhibitor (sintilimab) and chemotherapy in inducing systemic CD8+ T cell responses and achieving improved gastric cancer patient outcomes than with sintilimab and chemotherapy alone.

Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gastric Cancer

A Prospective, Randomized Controlled Clinical Study of The Efficacy and Safety of Taurine Combined With Sintilimab and Chemotherapy Versus Sintilimab Combined With Chemotherapy for Treatment of Advanced Gastric Cancer

Changes in number, apoptosis rate, effector (TNF-α, IFN-γ, etc.) production and immune checkpoint molecule (PD-1, CTLA-4, etc.) expression of CD8+ T cells in peripheral venous blood assessed via flow cytometry.

Changes in number, effector (TNF-α, IFN-γ, etc.) production and immune checkpoint molecule (PD-1, CTLA-4, etc.) expression of tumor-infiltrating CD8+ T cells in gastric cancer endoscopic biopsy material assessed via immunohistochemistry.

PFS was defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 based on independent radiology review or death due to any cause, whichever occurs first.

OS was defined as the time from randomization to death due to any cause.

ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.

Number of study subjects experiencing adverse events (AEs), dose-limiting toxicities, and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.

Tang-Du Hospital

Adenocarcinoma

Docetaxel

Immunomodulating Agents

Taurine + Serplulimab + XELOX or Taurine + Serplulimab + FLOT

Serplulimab + XELOX or Serplulimab + FLOT

Serplulimab

Fluorouracil + leucovorin + oxaliplatin + docetaxel

FLOT regimen

This project aims to evaluate the efficacy and safety of oral taurine supplementation combined with PD-1 inhibitor (serplulimab) and chemotherapy in inducing systemic CD8+ T cell responses and achieving improved gastric cancer patient outcomes than with serplulimab and chemotherapy alone.

Prospective, randomized controlled clinical study

Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer

A Prospective, Randomized Controlled Clinical Study of The Efficacy and Safety of Taurine Combined With Serplulimab and Chemotherapy Versus Serplulimab Combined With Chemotherapy for Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

To evaluate the pathologic complete response rate of locally advanced gastric cancer treated with concurrent serplulimab with chemotherapy with or without taurine supplementation.

The surgical margin is microscopically-negative for residual tumor.

Residual tumor cells below 10% in the resected specimen.

DFS was defined as the time from surgery to postoperative recurrence or death from any cause, whichever occurred first. DFS was censored on the last tumor assessment date for patients still alive and without recurrence.

EFS was the time from enrollment to recurrence or death from any cause. EFS was censored on the last tumor assessment date for patients still alive and without recurrence.

OS was the time from enrolment to death from any cause. OS was censored on the last date known to be alive for patients without documentation of death.

Changes in number, effector (TNF-α, IFN-γ, etc.) production and immune checkpoint molecule (PD-1, CTLA-4, etc.) expression of tumor-infiltrating CD8+ T cells in gastric cancer endoscopic biopsy or surgical resection material assessed via flow cytometry and immunohistochemistry.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Camrelizumab Combined With Trastuzumab and Chemotherapy in Patients With HER2-positive Advanced Colorectal Cancer	NCT05193292	Colorectal Neop... Intestinal Neop...	Camrelizumab Trastuzumab XELOX regimen mFOLFOX6 regime... FOLFIRI regimen mXELIRI regimen mIRIS regimen	18 Years -	Fudan University
Clinical Study of Apatinib and XELOX Combination Regimen to Treat Colorectal Cancer Patients	NCT02829385	Colorectal Neop...	Apatinib and XE...	18 Years - 75 Years	LanZhou University
Camrelizumab Combined With Trastuzumab and Chemotherapy in Patients With HER2-positive Advanced Colorectal Cancer	NCT05193292	Colorectal Neop... Intestinal Neop...	Camrelizumab Trastuzumab XELOX regimen mFOLFOX6 regime... FOLFIRI regimen mXELIRI regimen mIRIS regimen	18 Years -	Fudan University
Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gastric Cancer	NCT06123455	Gastric Cancer	Taurine Sintilimab XELOX regimen SOX regimen FOLFOX regimen	18 Years -	Tang-Du Hospital
Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer	NCT06128252	Gastric Cancer	Taurine Serplulimab XELOX regimen FLOT regimen	18 Years - 75 Years	Tang-Du Hospital
Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gastric Cancer	NCT06123455	Gastric Cancer	Taurine Sintilimab XELOX regimen SOX regimen FOLFOX regimen	18 Years -	Tang-Du Hospital
Clinical Study of Apatinib and XELOX Combination Regimen to Treat Colorectal Cancer Patients	NCT02829385	Colorectal Neop...	Apatinib and XE...	18 Years - 75 Years	LanZhou University

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