Neoplasms

Digestive System Diseases

All Conditions

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

125mg/m2, d1, 8, intravenous infusion for 30min, 1 cycle every 3 weeks;Other combined chemotherapy drugs and drug doses shall be administered by clinicians according to the guidelines and the actual situation of clinical patients.

Albumin binding taxol

Xifang Hou

The purpose of this study was to evaluate the safety and efficacy of domestic injection paclitaxel (albumin binding type) in patients with advanced digestive tract tumors,and to further explore the possible predictors of efficacy.In order to provide more effective chemotherapeutic drugs, prolong survival time and improve quality of life for patients with advanced digestive tract tumors.

Treatment of Advanced Gastrointestinal Tumors With Albumin Taxol

A Retrospective Clinical Study on the Efficacy and Safety of Injection Taxol (Albumin Binding Type) in the Treatment of Patients With Advanced Gastrointestinal Tumors

Progression free survival (PFS) is the time between the onset of treatment and the observation of disease progression or death from any cause.

Defined as the proportion of patients with a documented complete response, and partial response (CR+PR)

The Overall survival (OS) is defined as the date from random grouping to death from any cause.

Henan Cancer Hospital

14-O-phosphonooxymethyltriptolide disodium salt

Antineoplastic Agents, Alkylating

Alkylating Agents

A Phase 1, Multi-Center, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Minnelide™ given daily for 21 days followed by 7 days off schedule in patients with Advanced GI Tumors

Minnelide™ will be given as a single agent intravenously as a 30-minute infusion daily x 21 days followed by a 7-day rest period. One cycle will equal 28 days.

Minnelide™ 001

Mohana Velagapudi, MD

Linda Vocila, BSN

The primary objective of this study is to determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of Minnelide™ and to establish the dose of Minnelide™ recommended for future phase 2 protocol

This is a Phase 1, open label, multicenter, dose-escalation study of safety, pharmacokinetics, and pharmacodynamics of Minnelide™

Minnelide™ will be given as a single agent intravenously as a 30-minute infusion daily x 21 days followed by a 7-day rest period. One cycle will equal 28 days. Dose escalation will follow a modified Fibonacci design.

Study of Minnelide™ in Patients With Advanced GI Tumors

A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Minnelide™ Given Daily for 21 Days Followed by 7 Days Off Schedule in Patients With Advanced GI Tumors.

The MTD will be determined using a 3 + 3 design and will continue until 2 patients at any dose level experience a DLT. A DLT will be defined as Grade 4 neutropenia lasting ≥ 5 days or Grade 3 or 4 neutropenia with fever and/or infection;Grade 4 thrombocytopenia (or Grade 3 with bleeding);Grade 3 or 4 treatment-related non-hematological toxicity (Grade 3 nausea, vomiting or diarrhea that last \> 72 hours despite maximal treatment constitutes a DLT, insufficient treatment will not constitute an exception to the DLT criteria, as this would constitute inadequate conduct of the study); Dosing delay greater than 2 weeks due to treatment-emergent AEs or related severe laboratory abnormalities.

Once the MTD has been determined this will be the dose going forward in phase 2 studies

Plasma concentration data will be used to determine the following PK parameters:

* AUC Area under the concentration curve
* Cmax Maximum plasma concentration
* Tmax Time to maximum plasma concentration
* t1/2 Terminal phase half life
* CL/F Total body clearance
* Vd/F Apparent volume of distribution

Objective measurements of tumor size will be recorded from PET, CT scan and other measures.

As part of exploratory PD, the following assessments will be performed:

* Biomarkers including CA19-9 (or CA125, CEA if non-secretors for pancreas cancer), CEA and CA125 as applicable, any tumor marker appropriate to the given cancer or that is known to be elevated in a given patient will be evaluated according the Investigator's discretion, prior to every Cycle.
* Serum HSP70 levels
* PET Scans
* Evaluation of CT scans using Choi criteria

Minneamrita Therapeutics LLC

Rare Diseases

Gastrointestinal Stromal Tumors

Sunitinib

Imatinib Mesylate

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

150 mg QD of ripretinib (3×50 mg tablets) will be dosed continuously in repeated 42-day cycles.

50 mg QD of sunitinib (4×12.5 mg capsules) will be dosed in 42-day cycles. Sunitinib will be given continuously for 4 weeks with a 2-week break.

Ripretinib

Clinical Team

This is a Phase 3, 2-arm, randomized, open-label, global, multicenter study comparing the efficacy of ripretinib to sunitinib in participants with GIST who progressed on first-line treatment with imatinib, harbor co-occurring KIT exons 11+17/18 mutations, and are without KIT exon 9, 13, or 14 mutations. Upon disease progression as determined by an independent radiologic review, participants randomized to sunitinib will be given the option to either crossover to receive ripretinib 150 mg QD or discontinue sunitinib.

A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib

An International, Phase 3, Randomized, Multicenter, Open-label Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With KIT Exon 11 and Co-occurring KIT Exons 17 and/or 18 Mutations Who Were Previously Treated With Imatinib

The time from randomization until documented progressive disease (PD) based on IRR per mRECIST or death due to any cause, whichever occurs first.

Compare ORR by IRR of ripretinib vs sunitinib using mRECIST

Deciphera Pharmaceuticals LLC

Bevacizumab

Irinotecan

Antibodies

Antibodies, Monoclonal

Camptothecin

Immunoglobulins

Endothelial Growth Factors

Mitogens

Antineoplastic Agents, Immunological

Topoisomerase I Inhibitors

Escalating doses (20-35 mg/m2/dose, based on tolerability), orally, twice daily on days 1-5 of each 14-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.

TAS-102

Escalating doses (30-minute infusion of 120-180 mg/m2/dose, based on tolerability), IV (in the vein) on Day 1 of each 14-day treatment cycle. Number of cycles: until at least one of the discontinuation criteria is met.

CPT-11

Dose (infusion of 5 mg/kg administered per site standard practice), IV (in the vein) on Day 1 of each 14-day treatment cycle. Number of cycles: until at least one of the discontinuation criteria is met.

Leonard Saltz, MD

The purpose of this study is to investigate the safety and determine the maximum tolerated dose of TAS-102 administered in combination with CPT-11 in patients with advanced gastrointestinal tumors.

This is an open-label, non-randomized, dose-escalation, Phase 1 study of TAS-102 administered in combination with CPT-11. The study will be conducted in 2 parts: a Dose Escalation Phase (Part 1) to determine the maximum tolerated dose and an Expansion Phase (Part 2) to further evaluate the safety, pharmacokinetics, and preliminary efficacy of the maximum tolerated dose. Patients will be assigned to sequential dose-level cohorts with each cohort corresponding to a pre-specified dose of TAS-102 and CPT-11 combination. Escalation to the subsequent dose level will occur only after the previous dose level is determined to be safe.

A Phase I Study of TAS-102 in Patients With Advanced Gastrointestinal Tumors.

A Phase 1, Open-label, Non-randomized, Dose-escalating Safety, Tolerability, and Pharmacokinetic Study of TAS-102 in Combination With CPT-11 and Bevacizumab in Patients With Advanced Gastrointestinal Tumors

The maximum tolerated dose is defined as the highest dose level at which less than 33% of the evaluable patients treated experience a dose-limiting toxicity during Cycle 1 or Cycle 2 (ie, during the first 4 weeks) of study drug administration.

Standard safety monitoring and grading using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) will be used.

PK analysis for FTD, FTY, TPI, CPT-11, and SN-38 in plasma and will include Cmax, Tmax, AUC0-last, AUC0-inf, and T1/2. FTD and TPI: CL/F, Vd/F will be calculated.

Tumor assessments using Response Evlauation Criteria in Solid Tumors (RECIST)

Taiho Oncology, Inc.

Donafenib 50mg BID/100 mg BID/200 mg BID orally + KN046 5mg/kg Q3W iv

In the dose exploration phase (phase I) : three doses of Donafenib tosylate tablets \[50 mg twice a day; 100 mg twice a day; 200 mg twice a day \] will be explored. In the dose expansion phase (phase II), patients with advanced hepatocellular carcinoma will be treated at the recommended dose for phase 2(RP2D).The RP2D will be determined by the dose escalation study.

Donafenib Tosilate Tablets

KN046 Injection

Tianshu Liu, PhD

Tianshu Liu

This study is an open, multi-center clinical trial, the purpose is to study the safety and preliminary efficacy of Donafenib combined with KN046 in subjects with Advanced Gastrointestinal Tumors.

The study consists of dose escalation and dose expansion. The preset dose of Donafenib is 50 mg BID, 100 mg BID and 200 mg BID, and the preset dose of KN046 is 5 mg/kg Q3W. Dose expansion will enroll subjects who with advanced hepatocellular carcinoma.

A Phase 1/2 Study of Donafenib in Combination With KN046 in Advanced Gastrointestinal Tumors

A Phase 1/2 Dose Escalation and Expansion Study of Donafenib Tosilate Tablets in Combination With KN046 Injection in Advanced Gastrointestinal Tumors

Evaluated by severity of drug-related adverse events (AEs), serious adverse events (SAEs).

Objective response rate based on the RECIST 1.1 by investigator. Percentage of subjects achieving complete response (CR) and partial response (PR).

It is defined as time between the date of first radiographic documented objective response and the date of the radiographic documented disease progression.

PFS is defined as the time from date of enrollment to the date of the first objectively documented tumor progression or death due to any cause.

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Antirheumatic Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Prior to infusion of the LCAR-G08, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.

LCAR-G08 cells

Lin Shen

Changsong Qi

Lin Shen, MD

Yanshuo Cao, MD

Zhihao Lu, MD, PhD

Jun Zhou, MD, PhD

Chang Liu, MD, PhD

This is a phase 1, single-arm, open-label, dose escalation and expansion study of LCAR-G08 in adult subjects with advanced gastrointestinal tumors expressing guanylyl cyclase C (GCC).

This is a phase 1, single-arm, open-label, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the cell-based LCAR- G08 in subjects with guanylyl cyclase C (GCC)-positive advanced gastrointestinal tumors. Subjects who meet the eligibility criteria will receive LCAR-G08 infusion. The study will include the following sequential phases: screening, pre-treatment (cell product preparation; lymphodepleting chemotherapy), treatment and follow up.

A Study of LCAR-G08 in Subjects With Advanced Gastrointestinal Tumors Expressing Guanylyl Cyclase C (GCC)

A Phase 1, Open-Label Study Evaluating the Safety, Tolerability and Efficacy of (LCAR)-G08, a Chimeric Antigen Receptor (CAR)-T Cell Therapy Targeting Guanylyl Cyclase C (GCC) in Subjects With Advanced Gastrointestinal Tumors

Dose-limiting toxicity (DLT) refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose.

An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.

RP2D established through accelerated titration design (ATD) and Bayesian Optimal Interval (BOIN) design.

The maximum observed concentration of CAR positive T cells or transgene CAR copy number after LCAR-G08 infusion.

The time it takes to reach the maximum concentration or time to Cmax after LCAR-G08 infusion.

The time it takes to reach the last observed concentration after LCAR-G08 infusion.

The total exposure of the drug experienced by the subject in a clinical study from LCAR-G08 infusion to time to the last observed concentration.

Objective Response Rate (ORR) is defined as the proportion of subjects who achieve complete response (CR) or partial response (PR) after treatment via LCAR-G08 cell infusion, and the objective tumor response rate will be calculated for patients with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 only.

Disease Control Rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease.

Duration of Remission (DoR) is defined as the time from the first documentation of remission (PR or better) to the first documented disease progression evidence (according to RECIST 1.1) of the responders (who achieve PR or better response).se).

Time to Response (TTR) is defined as the time from the date of first infusion of LCAR-G08 to the date of the first response evaluation of the subject who has met all criteria for PR or better.

Progression-free Survival (PFS) is defined as the time from the date of first infusion of the LCAR-G08 to the first documented disease progression (according to RECIST 1.1) or death (due to any cause), whichever occurs first.

Overall Survival (OS) is defined as the time from the date of first infusion of LCAR-G08 to death of the subject.

Venous blood samples will be collected to measure LCAR-G08 positive cell concentrations and the transgenic level of LCAR-G08, at the time points when anti-LCAR-G08 antibody serum samples are evaluated.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Treatment of Advanced Gastrointestinal Tumors With Albumin Taxol	NCT03977077	Advanced Gastro...	Albumin binding...	18 Years - 75 Years	Henan Cancer Hospital
Study of Minnelide™ in Patients With Advanced GI Tumors	NCT01927965	Advanced Gastro...	Minnelide™ 001	18 Years -	Minneamrita Therapeutics LLC
A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib	NCT05734105	GIST	Ripretinib Sunitinib	18 Years -	Deciphera Pharmaceuticals LLC
A Phase I Study of TAS-102 in Patients With Advanced Gastrointestinal Tumors.	NCT01916447	Advanced Gastro...	TAS-102 CPT-11 Bevacizumab	18 Years -	Taiho Oncology, Inc.
A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib	NCT05734105	GIST	Ripretinib Sunitinib	18 Years -	Deciphera Pharmaceuticals LLC
A Phase 1/2 Study of Donafenib in Combination With KN046 in Advanced Gastrointestinal Tumors	NCT04612712	Advanced Gastro...	Donafenib Tosil... KN046 Injection	18 Years - 70 Years	Suzhou Zelgen Biopharmaceuticals Co.,Ltd
A Study of LCAR-G08 in Subjects With Advanced Gastrointestinal Tumors Expressing Guanylyl Cyclase C (GCC)	NCT06197178	Advanced Gastro...	LCAR-G08 cells	18 Years - 70 Years	Peking University

Spots Global Cancer Trial Database for advanced gastrointestinal tumors