Cadonilimab Injection in combination with Regorafenib

Cadonilimab Injection, 6mg/kg, intravenous drip ,q2w,

Cadonilimab Injection

Regorafenib

Huikai Li, MD

Xihao Zhang, Doctor

Xihao zhang, Doctor

To evaluate the efficacy and safety of Cadonilimab Injection in combination with Regorafenib in the treatment of intermediate to advanced biliary systemic tumours that has failed at least one prior systemic therapy

An open, single-arm, single-centre clinical study evaluating Cadonilimab Injection in combination with Regorafenib for the treatment of biliary systemic tumours that have failed at least one prior systemic therapy

A Study Evaluating Cadonilimab Injection in Combination With Regorafenib for the Treatment of Biliary Systemic Tumours

An Open, Single-arm, Single-centre Clinical Study Evaluating Cadonilimab Injection in Combination With Regorafenib for the Treatment of Biliary Systemic Tumours That Have Failed at Least One Prior Systemic Therapy

Defined as proportion of patients who have a best response of CR or PR

OS is defined as the time from date of neoadjuvant treatment start to the date of death from any cause or to the date of last follow-up if patients are alive. If a patient is alive by the time of final analysis, the patient will be censored at the last follow-up date.

Defined as the time from enrollment to disease progression or death (whichever occurs first)

Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0

Tianjin Medical University Cancer Institute and Hospital

Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Disease Progression

Esophageal Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Stomach Cancer

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Disitamab vedotin

Tubulin Modulators

Antimitotic Agents

Immunoconjugates

Immunologic Factors

Phase II and III study ：2.5mg/kg, intravenous infusion，D1, every 2 weeks

Disitamab Vedotin Injection

Phase II and III study ：6.0mg/kg, intravenous infusion，D1, every 2 weeks.

Phase II and III study ：Calculate dosage based on body surface are,160mg/m2,intravenous infusion，D1,D8 every 3 weeks

Paclitaxel Injection

Jianmin Fang, Ph.D

Lin Shen, M.D.

Lin Shen, M.D

Feng Ye, M.D

Yanqiao Zhang, M.D

Yanru Qin, M.D

Huiting Xu, M.D

Zhenyang Liu, M.D

Yuan Yuan, M.D

Changzheng Li, M.D

Changzheng Li

Jing Lv, M.D

Jun Zhang, M.D

Hongfeng Gou, M.D

Lin Xie, M.D

The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin Combined with Cadonilimab in subjects with HER2-expressing locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma after progression on first-line therapy.

This is an open-label, randomized, multicenter, Phase II/III Study designed to evaluate safety and efficacy of Disitamab Vedotin Combined with Cadonilimab in subjects with HER2-expressing locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma after progression on first-line therapy.

This clinical study was divided into two parts, phase II and III.Part I: Phase II study primary objectives of the study are to evaluate the efficacy and safety of Disitamab Vedotin Combined with Cadonilimab versus Disitamab Vedotin versus paclitaxel in subjects with HER2-expressing locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma after progression on first-line therapy.

Part II: Phase III study primary objectives of the study are to evaluate the efficacy and safety of Disitamab Vedotin Combined with Cadonilimab versus paclitaxel in subjects with HER2-expressing locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma after progression on first-line therapy.

Tumor assessments, including radiological assessments by CT/MRI scans will be performed at Screening and subsequently every 6 weeks (±7 days) until disease progression, death, the start of new anticancer therapy, or patient's withdrawal of consent (whichever occurs first).

All patients who discontinue treatment will be followed for survival every 3 months until death, lost to follow-up, withdrawal of consent for survival follow-up, or end of study (whichever comes first).

DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy

A Randomized，Multicenter, Open-Label，Phase II/III Study to Evaluate the Safety and Efficacy of Disitamab Vedotin Combined With Cadonilimab in Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer and Gastroesophageal Junction Adenocarcinoma Who Have Progressed on r First-line Therapy

ORR assessed according to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1)

Number of participants with adverse effects of treatment. Frequency and severity of adverse effects of treatment as assessed by NCI CTCAE v5.0

PFS was defined as the time from random assignment to the onset of disease progression (as assessed by the IRC according to RECIST v1.1 criteria) or death (whichever event occurs first)

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

Percentage of patients with complete response, partial response, or stable disease for a certain period of time according to RECIST v1.1.

Defined as the time from the date of first documented response (CR/PR) until the first progression or death in the absence of disease progression by Investigators assessment according to RECIST 1.1

According to NCI-CTCAE Version 5.0 per each treatment arm

To be summarized using descriptive statistics

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study Evaluating Cadonilimab Injection in Combination With Regorafenib for the Treatment of Biliary Systemic Tumours	NCT05644392	Advanced Biliar...	Cadonilimab Inj... Regorafenib	18 Years - 75 Years	Tianjin Medical University Cancer Institute and Hospital
A Study Evaluating Cadonilimab Injection in Combination With Regorafenib for the Treatment of Biliary Systemic Tumours	NCT05644392	Advanced Biliar...	Cadonilimab Inj... Regorafenib	18 Years - 75 Years	Tianjin Medical University Cancer Institute and Hospital
DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy	NCT06221748	Gastric Cancer Gastroesophagea...	Disitamab Vedot... Cadonilimab Inj... Paclitaxel Inje...	18 Years - 75 Years	RemeGen Co., Ltd.

Spots Global Cancer Trial Database for cadonilimab injection