Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Oxaliplatin

Antibodies

Antibodies, Monoclonal

Capecitabine

Tin Fluorides

Antibodies, Bispecific

Immunoglobulins

Complement System Proteins

Mitogens

Tyrosine Kinase Inhibitors

Antimetabolites

Tyrosine

Initial treatment (4-6 cycles): IBI315 injection, oxaliplatin, capecitabine

* IBI315: 1200 mg per cycle d1 dosing, intravenous drip, 3 weeks as one treatment cycle.
* Oxaliplatin: 130 mg/m2, d1 per cycle, intravenous drip, 3 weeks as a treatment cycle.
* Capecitabine: 1000 mg/m2 orally twice daily (1 dose in the morning and 1 dose in the evening), d1-d14 per cycle, 2 weeks off 1 week, 3 weeks cycle.

Patients with CR/PR/SD enter maintenance therapy: IBI315 monotherapy maintenance

- IBI315: 1200 mg IV drip per cycle d1 for 3 weeks.

Initial treatment (4-6 cycles): PD-L1 monoclonal antibody, TST001 injection, oxaliplatin, capecitabine

* TST001: 3mg, 4.5mg and 6mg dose levels for hill climbing trial, dose per cycle d1, IV drip, 3 weeks for one treatment cycle. 3-6 patients were enrolled in each dose level (3 patients were enrolled if no DLT was present, if present extended to 6 patients)
* TQB2450 injection: 1200 mg per cycle d1 dosing, IV drip, 3 weeks as a treatment cycle.
* Oxaliplatin: 130 mg/m2 per cycle d1 dosing, intravenous drip, 3 weeks as a treatment cycle.
* Capecitabine: 1000 mg/m2 orally twice daily (1 dose in the morning and 1 dose in the evening), d1-d14 per cycle, 2 weeks off 1 week, 3 weeks cycle.

Patients with CR/PR/SD enter maintenance therapy: TQB2450 injection + TST001

* TST001: maintenance at the dose level used (3mg/4.5mg/6mg), dosed d1 per cycle, IV drip, 3 weeks as a treatment cycle.
* TQB2450 injection: 1200mg, dosed d1 per cycle, intravenous drip, 3 weeks as a treatment cycle.

Initial treatment (4-6 cycles): TQB2450 injection, Anrotinib, Oxaliplatin, Capecitabine

* TQB2450 injection: 1200mg per cycle d1 dosing, intravenous drip, 3 weeks as a treatment cycle.
* Anrotinib: 1 capsule (10 mg) once daily, dosed every cycle d1-d14, stopping for 2 consecutive weeks, 3 weeks as a treatment cycle
* Oxaliplatin: 130 mg/m2, d1 per cycle, intravenous drip, 3-week treatment cycle.
* Capecitabine: 1000 mg/m2 orally twice daily (1 dose in the morning and 1 dose in the evening), d1-d14 per cycle, 2 weeks off 1 week, 3 weeks as a treatment cycle.

Patients with CR/PR/SD enter maintenance therapy: PD-L1 inhibitor, anlotinib

* PD-L1 monoclonal antibody (TQB2450): 1200 mg d1 per cycle, intravenous drip, 3 weeks as a treatment cycle.
* Anlotinib: 1 capsule (10mg) once daily, d1-d14 per cycle, stopping for 2 weeks, 3 weeks as a treatment cycle.

IBI315 is a recombinant fully humanized anti-programmed death receptor 1 (PD-1) and humanized anti-human epidermal growth factor receptor 2 (HER2) bispecific antibody injection.

IBI315

Oxaliplatin is a type of chemotherapy. It is used as a treatment for different types of cancer, including gastric cancer.

Capecitabine is a type of chemotherapy. It is used as a treatment for different types of cancer, including gastric cancer.

TST001 is a high-affinity humanized monoclonal antibody targeting Claudin 18.2 with enhanced antibody-dependent cytotoxic (ADCC) and complement-dependent cytotoxic (CDC) activity, showing potent antitumor activity in xenograft assays.

TST001

TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.

TQB2450

Anlotinib is a novel multitarget tyrosine kinase inhibitor for tumor angiogenesis and proliferative signaling.

Anrotinib

Abstract Study title: Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes Protocol No: GC-MATCH Initiator: Henan Cancer Hospital Nature of study Investigator-initiated exploratory study Subjects Advanced first-line gastric cancer or adenocarcinoma of the gastroesophageal junction Objective: To evaluate the efficacy and safety of different first-line treatment options for unresectable locally advanced/advanced gastric or combined gastroesophageal adenocarcinoma with different gene/protein types.

Evaluation criteria: To evaluate the adverse effects of drugs using the NCI CTCAE V5.0 criteria.

RECIST1.1 criteria were used to evaluate drug efficacy Study endpoints: Primary indicators Objective Response Rate (ORR) Secondary indicators 1. drug safety. 2. disease control rate DCR (CR+PR+SD). 3. duration of remission DoR. 4. disease-free survival (PFS) and overall survival time (OS). 5. R0/R1 surgical resection rate Study design: Single-center umbrella clinical trial Planned number of enrollment: Total 39-45 cases Sample size estimation: This is an exploratory study and sample size was not calculated Statistical methods: Selection of data for statistical analysis Full Analysis Set (FAS): The efficacy analysis was performed on all patients who were enrolled and used the drug at least once, according to the principle of intentional analysis (ITT).

Per-protocol Set: Cases with at least one oncologic efficacy assessment, compliance with the trial protocol, good compliance, no prohibited drugs during the trial, and completion of the case report form.

Safety Analysis Set: All patients who had used the trial drug at least once and had a safety record after the drug was administered were enrolled in the Safety Analysis Set.

Statistical analysis plan Validity analysis: for the efficacy index PFS, the Kaplan-Meier method will be used to estimate its median time and column Statistical methods: Out of two-sided 95% confidence intervals. Disease control rate (DCR = CR+PR+SD) and objective remission rate (ORR = CR+PR) were calculated using Fisher exact probability and bilateral 95% confidence intervals were presented.

Safety analysis: descriptive statistical analysis was used to tabulate the AEs that occurred in this trial. laboratory test results were described as normal before the trial but abnormal after treatment and in relation to the trial drug when abnormal changes occurred.

Treatment protocol:

All subjects in this study were first tested for genes/proteins (HER2 protein, HER2FISH, PD-L1 protein 22C3, Claudin18.2, MMR) and received treatment in different groups according to gene/protein expression.

Group 1 HER protein positive 3+ or FISH amplification or HER protein 2+ but FISH amplification Initial treatment (4-6 cycles): IBI315 injection, oxaliplatin, capecitabine Group 2 Claudin18.2 protein-positive Initial treatment (4-6 cycles): PD-L1 monoclonal antibody, TST001 injection, oxaliplatin, capecitabine Group 3 Her protein and Claudin18.2 protein were negative Initial treatment (4-6 cycles): TQB2450 injection, Anrotinib, Oxaliplatin, Capecitabine Patients can undergo radical gastric cancer surgery or radical gastric cancer surgery + local treatment during the maintenance treatment phase if their condition is stable and after in-hospital MDT consultation. The duration of maintenance treatment was 2 years from the time of enrollment.

Principal Investigator: Luo Suxia, Li Ning Group leader unit: Henan Cancer Hospital

Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes

An adverse event contains multiple severity grades, typically the start date is the date of mild (grade 1) occurrence, the end date is the date of improvement, and the level is filled in at the highest level.

The remission period is usually defined as the period from the onset of efficacy until the confirmation of tumor progression. The objective remission rate is generally defined as the sum of complete remission plus partial remission (CR+PR).

Time from when the patient first achieved complete remission or partial remission to disease progression.

Time from randomization grouping of patients to disease progression or death from any cause.

From date of randomization until the date of death from any cause, assessed up to 100 months

Proportion of patients who achieve complete remission, partial remission, or disease control with optimal efficacy

Henan Cancer Hospital

Patients will receive IBI315 until disease progression, intolerability, informed consent withdraw, or other reasons leading to treatment discontinue.

Patients will receive IBI315 RP2D until disease progression,intolerability, informed consent withdraw, or otherreasons leading to treatment discontinue.

The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI315, a HER2/PD-1 bi-specific antibody in patients with advanced solid tumors

This phase Ia/Ib, open-label, multicenter study has two stages. The Ia stage is a dose-escalation study that will focus on safety, tolerability, efficacy and RP2D . Patients with HER2-expressing advanced solid tumor who failed from previous standard of care will be enrolled in the phase Ia study. DLT observation period is 28 days.

A Phase Ia/Ib Study of IBI315 in Patients With HER2-expressing Advanced Solid Tumor

A Phase Ia/Ib, Open-label, Multicenter, Dose-escalation Study Evaluating the Safety, Tolerability, and Potential Efficacy of IBI315, an Anti-HER2/PD-1 Bi-specific Antibody in Patients With HER2-expressing Advanced Solid Tumor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes	NCT05608785	Gastric Cancer Gastroesophagea...	IBI315 Oxaliplatin Capecitabine TST001 TQB2450 Anrotinib	18 Years - 75 Years	Henan Cancer Hospital
A Phase Ia/Ib Study of IBI315 in Patients With HER2-expressing Advanced Solid Tumor	NCT04162327	Advanced Solid ...	IBI315 IBI315	18 Years - 75 Years	Innovent Biologics (Suzhou) Co. Ltd.
Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes	NCT05608785	Gastric Cancer Gastroesophagea...	IBI315 Oxaliplatin Capecitabine TST001 TQB2450 Anrotinib	18 Years - 75 Years	Henan Cancer Hospital

Spots Global Cancer Trial Database for ibi315

Every month we try and update this database with for ibi315 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ibi315

Every month we try and update this database with for ibi315 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ibi315 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.