Neoplasms

All Conditions

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Sarcoma

Ichthyosis, X-Linked

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

The subject will be treated with Candonilimab + anlotinib every 21 days as a treatment cycle: Candonilimab 10mg/kg, D1 administration; Anlotinib 12mg/ day was taken orally for 2 weeks and stopped for a week. Until the subject has disease progression, intolerable toxicity, and the investigator's decision, the subject withdraws informed consent, death or other reasons specified in the protocol.

The patients were treated with Candonilimab + anlotinib, with Cadonilimab 10mg/kg, D1 administration; Anlotinib 12mg/ day was orally administered for 2 weeks and stopped for a week, with 21 days as a course of treatment.

Candonilimab

Ying Dong

Rui Bai

Objective to evaluate the efficacy and safety of candonilimab combined with anlotinib in the treatment of progressive or metastatic soft tissue sarcoma that failed previous first-line standard therapy.

Efficacy and Safety of Cadonilimab Plus Anlotinib in Advanced STS That Failed the Previous First-line Standard Treatment

Efficacy and Safety of Cadonilimab Combined With Anlotinibin in the Treatment of Advanced or Metastatic Soft Tissue Sarcoma With Previous First-Line Standard Treatment Failure.

The proportion of patients whose tumor volume reduced by 30% and could maintain for more than 4 weeks, that is, the sum of the proportion of complete remission (CR) and partial remission (PR)

The percentage of disease remission (including complete remission and partial remission, pr+cr) and stable disease (SD) in the number of evaluable cases after treatment

Remission duration refers to the time from the first CR or PR to disease progression.

It refers to the overall time from the time of tumor occurrence to the patient's death

Time from randomization to disease progression

The overall survival time of tumor patients

The incidence and severity of adverse events (AES) and clinically significant abnormal laboratory test results.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Atezolizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Candonilimab 10mg/kg, Bevacizumab 15mg/kg, every 3 week

Ming Shi, MD

To explore the efficacy and safety of candonilimab plus bevacizumab for patients with advanced hepatocellular carcinoma who progressed on atezolizumab plus bevacizumab.

Atezolizumab plus bevacizumab is the first-line treatent for patients with advanced hepatocellular carcinoma. However, the second-line treatment is absent for patients who progressed on atezolizumab plus bevacizumab. Candonilimab is a humanized bisspecific monoclonal antibody against PD-1/ CTLA-4 IgG1. Candonilimab plus lenvatinib showed strong anti-tumor effect, with objective response of 44%. This single-arm, prospective, phase 2 trial is to explore the efficacy and safety of candonilimab plus bevacizumab for patients with advanced hepatocellular carcinoma who progressed on atezolizumab plus bevacizumab.

Candonilimab Plus Bevacizumab for Patients With Advanced HCC Who Progressed on A+T

Candonilimab Plus Bevacizumab as Second-line Treatment for Patients With Advanced Hepatocellular Carcinoma Who Progressed on Atezolizumab Plus Bevacizumab: a Single Arm, Phase 2 Trial

DCR （Disease Control Rate） include complete response, partial response and stable Disease per RECIST 1.1

OS is the length of time from the date of randomization until death from any cause.

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

Objective response rate (complete response+partial response) per RECIST 1.1

Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report.

The blood specimen and needle biopsy specimen would be collected

Shi Ming

Proffessor

Atezolizumab plus bevacizumab is the first-line treatent for patients with advanced hepatocellular carcinoma. However, the second-line treatment is absent for patients who progressed on atezolizumab plus bevacizumab. Candonilimab is a humanized bisspecific monoclonal antibody against PD-1/CTLA-4 IgG1. Candonilimab plus lenvatinib showed strong anti-tumor effect, with objective response of 44%. This single-arm, prospective, phase 2 trial is to explore the efficacy and safety of candonilimab plus bevacizumab for patients with advanced hepatocellular carcinoma who progressed on atezolizumab plus bevacizumab.

Biliary Tract Neoplasms

Biliary Tract Diseases

Biliary Tract Cancer

Antibodies

Antibodies, Bispecific

Immunoglobulins

Immunologic Factors

6 mg/kg cardonilizumab, 14 days for 1 course.

1.8mg /mg LM-302 was treated for 1 course for 14 days.

6 mg/kg cardonilizumab for 14 days was a course of treatment; RP2D LM-302 is 1 course of treatment for 14 days

cardonilizumab:PD1 and CTLA-4 bispecific antibody

cardonilizumab

LM-302

Guo-Ming Shi, MD

Xiao-Yong Huang, MD

Jia Fan, MD

In this clinical study, we will evaluate the efficacy and safety of cardonilimumab (PD1 monoclonal antibody and CTLA-4 monoclonal antibody bisspecific antibodies) and LM-302 (Claudin18.2-ADC) in Claudin18.2-positive advanced BTC patients who have progressed after SOC and PD1/PD-L1 monoclonal antibody treatment.

The prognosis for unresectable and metastatic biliary malignancies (BTC) is extremely poor, with a median overall survival of only about 1 year for advanced biliary tumors treated with gemcitabine and cisplatin or combined with duvaliumab (PD-L1) as recommended by NCCN guidelines. At present, the NCCN guidelines recommend that the posterior line treatment of advanced BTC, such as FOLFOX, has a very limited effect, with an objective response rate of only about 5% and a median survival time of only about 6 months. There is an urgent need to develop new therapeutic methods to improve patient survival. Chronic inflammation caused by viral infection and bile duct stones are the most common potential risk factors for BTC, and immune system abnormalities play a key role in the occurrence and development of BTC. BTC, including intrahepatic cholangiocarcinoma (iCCA), showed abnormal expression of immune checkpoint molecules PD-L1 and CTLA-4 and obvious heterogeneity. Therefore, immunotherapy is of great value. TOPAZ-1 and KENOTE-966 studies both showed the value of PD-L1/PD1 monoclonal antibody in the treatment of advanced BTC. There is currently a lack of treatment options for progression after treatment with standard chemotherapy (SOC) combined with PD-L1/PD1 monoclonal antibodies. CTLA-4 inhibitors combined with PD-1/PD-L1 inhibitors have shown significantly enhanced clinical effects. Clinical studies on treating CTLA-4 inhibitors combined with PD-1/PD-L1 inhibitors have been carried out in several solid tumors. Although significant therapeutic effects have been achieved, adverse reactions (AEs) that cannot be ignored limit the benefit of patients. Claudin18.2 is a newly discovered tumor therapeutic target. Multiple clinical studies have shown that Claudin18.2 monoclonal antibody, Claudin18.2-ADC, and Cart-Claudin18.2 have good ORR in Claudin18.2-positive gastric cancer. At present, no independent research data on advanced BTC has been reported.

In this clinical study, we will evaluate the efficacy and safety of cardonilimumab (PD1 monoclonal antibody and CTLA-4 monoclonal antibody bispecific antibodies) and LM-302 (Claudin18.2-ADC) in Claudin18.2-positive advanced BTC patients who have progressed after SOC and PD1/PD-L1 monoclonal antibody treatment.

Each cycle of the first phase was defined as cardonilizumab (6mg/kg,Q2W) combined with different concentrations of 1.6mg/kg or 1.8mg/kg LM-302 (Q2W), 14 days as a course of treatment, and the combined dose (RP2D) of LM-302 during combination therapy was determined according to the 3+3 design.

In the second phase, Claudin18.2 expression was positive, and the positive population was randomly assigned to trial group 1, trial group 2, and trial group 3.

Group 1:6 mg/kg cardonilizumab, 14 days for 1 course. Group 2:1.8mg /mg LM-302 was treated for 1 course for 14 days. Group 3: 6 mg/kg cardonilizumab for 14 days was a course of treatment; RP2D LM-302 is 1 course of treatment for 14 days.

Candonilimab in Combination With LM-302 for Claudin 18.2 Positive-advanced Biliary Tract Cancer After Failure of Standard of Chemotherapy and PD1/PD-L1 Antibody

Two Stage, Multi-center Trial of Candonilimab in Combination With LM-302 for Treatment of Patients With Claudin 18.2 Positive-advanced Biliary Tract Cancer After Failure of Standard of Chemotherapy and PD1/PD-L1 Antibody

Objective response rate (ORR) in patients with Claudin18.2-positive treated with cardonillizumab combined with LM302 (RECIST 1.1)(Phase II)

Safety of cardonilizumab in combination with different doses of LM-302 in patients with advanced BTC

Shanghai Zhongshan Hospital

Cholangiocarcinoma

Bile Duct Cancer

Gemcitabine

Cisplatin

Antimetabolites

This study is a single-arm study to evaluate the safety and efficacy of candonilimab combined with cisplatin and gemcitabine in advanced biliary tract tumors

Candonilimab 10mg/kg, Ivgtt，Q3W，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；

Cisplatin，25mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；

gemcitabine 1000mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；

Candonilimab 10mg/kg, Ivgtt，Q3W，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；

Cisplatin，25mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；

gemcitabine 1000mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；

Tao Wang

Tao Wang, Dr.

The goal of this single-arm, Phase II interventional clinical trial is to test the safety and effectiveness of a combination treatment using the Cadonilimab with Gemcitabine and Cisplatin in patients with unresectable, locally advanced or metastatic biliary tract malignancies. The main questions it aims to answer are:

* Is this combined treatment protocol safe for these patients?
* Is this combined treatment protocol effective in treating these patients?

Participants will be given a combination treatment of Cadonilimab, Gemcitabine, and Cisplatin. Researchers will monitor their health conditions to assess the safety and effectiveness of this treatment protocol.

Cadonilimab With Chemotherapy in Treating Advanced Biliary Cancer

Efficacy and Safety of Cadonilimab Combined With Gemcitabine and Cisplatin in the First-line Treatment of Unresectable Locally Advanced or Metastatic Biliary Malignancies

To evaluate the overall survival (OS) in order to assess the efficacy and safety of Candonilimab in combination with cisplatin and gemcitabine treatment.

To evaluate the progression free survival (PFS) in order to assess the efficacy and safety of Candonilimab in combination with cisplatin and gemcitabine treatment.

Defined as the proportion of the subjects who have a complete response (CR) and partial response (PR) per RECIST 1.1 in enrolled subjects

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety of Cadonilimab Plus Anlotinib in Advanced STS That Failed the Previous First-line Standard Treatment	NCT05926700	Soft Tissue Sar...	Candonilimab	18 Years - 70 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
Candonilimab Plus Bevacizumab for Patients With Advanced HCC Who Progressed on A+T	NCT05760599	Hepatocellular ...	Candonilimab Bevacizumab	18 Years - 75 Years	Sun Yat-sen University
Candonilimab Plus Bevacizumab for Patients With Advanced HCC Who Progressed on A+T	NCT05886257	Hepatocellular ...	Candonilimab Bevacizumab	18 Years - 75 Years	Sun Yat-sen University
Candonilimab in Combination With LM-302 for Claudin 18.2 Positive-advanced Biliary Tract Cancer After Failure of Standard of Chemotherapy and PD1/PD-L1 Antibody	NCT05994001	Biliary Tract C... Candonilimab Claudin 18.2	cardonilizumab LM-302	18 Years -	Shanghai Zhongshan Hospital
Cadonilimab With Chemotherapy in Treating Advanced Biliary Cancer	NCT05978609	Cholangiocarcin...	Candonilimab Cisplatin Gemcitabine	18 Years - 75 Years	West China Hospital
Candonilimab in Combination With LM-302 for Claudin 18.2 Positive-advanced Biliary Tract Cancer After Failure of Standard of Chemotherapy and PD1/PD-L1 Antibody	NCT05994001	Biliary Tract C... Candonilimab Claudin 18.2	cardonilizumab LM-302	18 Years -	Shanghai Zhongshan Hospital

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