Neoplasms

All Conditions

Digestive System Diseases

Infections

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Adenoviridae Infections

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Oxaliplatin

Leucovorin

Fluorouracil

Liver Extracts

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

Patients receive oxaliplatin, 5-fluorouracil and leucovorin and recombinant human type-5 adenovirus 0.5ml via hepatic artery

Patients receive oxaliplatin, 5-fluorouracil and leucovorin and normal saline via hepatic artery

administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

HAIC of FOLFOX

Patients receive H101 0.5ml dissolved in 10ml normal saline in each session of HAIC

H101

Patients receive normal saline 10ml in each session of HAIC

Placebos

Ming Shi, MD

Hepatic artery infusion chemotherapy (HAIC) is effective and safe for hepatocellular carcinoma (HCC). Recombinant Human Type-5 Adenovirus (H101) is safe for HCC. The purpose of this study is to evaluate the efficacy and safety of HAIC combined with H101 compared with HAIC alone in patients with unresectable hepatocellular carcinoma (HCC) at barcelona clinic liver cancer A-B stage.

HAIC Plus H101 vs HAIC Alone for Unresectable HCC at BCLC A-B

Hepatic Artery Infusion Chemotherapy Plus Recombinant Human Type-5 Adenovirus vs Hepatic Artery Infusion Chemotherapy Alone for Unresectable Hepatocellular Carcinoma at Barcelona Clinic Liver Cancer A-B Stage

OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.

PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.

Postoperative adverse events were graded based on CTCAE v4.03

Sun Yat-sen University

Proffessor

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Pancreatic Cancer

Lenvatinib

Tislelizumab

Protein Kinase Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Immunological

(Dose escalation and cohort expansion) H101 administered by intratumoral injection in combination with Tislelizumab administered intravenously (IV), and Lenvatinib administered orally.

H101 intratumorally injection starts at day 0.

Tislelizumab plus lenvatinib will be initiated on day 1. Tislelizumab will be administered at 200 mg i.v. every 3 weeks orally daily every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

lenvatinib (bodyweight ≥ 60 kg, 12 mg; \< 60 kg, 8 mg) orally daily every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

lenvatinib

Peng Wang, MD

The objective of this study is to evaluate the safety/tolerability efficacy of oncolytic virotherapy combined with Tislelizumab plus lenvatinib for advanced pancreatic cancer patients who were relapsed or refractory to standard therapy

Recent studies have suggested that local destruction of tumor tissue by oncolytic virus induced activation and maturation of dendritic cells and tumor-specific T cells by cross-presentation of tumor antigens. While pd-1 blocking antibody interferes with PD-1 mediated T-cell regulatory signaling. And combination of pd-1 blocking antibody plus lenvatinib showed increased ORR in many types of human cancers. Therefore, the objective of this study is to evaluate the safety and efficacy of oncolytic virotherapy combined with Tislelizumab plus lenvatinib for advanced pancreatic cancer patients who were relapsed or refractory to standard therapy.

Oncolytic Virotherapy Plus PD-1 Inhibitor and Lenvatinib for Patients With Advanced Pancreatic Cancer

A Phase 1b Dose-escalation and Cohort-expansion Study of the Safety/Tolerability, and Efficacy of Oncolytic Virotherapy Plus PD-1 Inhibitor and Lenvatinib for Patients With Advanced Pancreatic Cancer

The DLT assessment period is defined as: Day of Injection through 28 days post injection (Safety Follow Up). A DLT will be defined as any Grade 3 or higher adverse event, as assessed by the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.

A MTD is determined if any cohort experiences 2 subjects with DLT's.

Fudan University

Professor

Virus Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Immune Checkpoint Inhibitors

* H101 intratumorally injection starts at day 1.
* Camrelizumab will be administered at 200 mg i.v. every 3 weeks at day 2.
* After two cycles of treatment, Camrelizumab will be administered alone at 200 mg i.v. every 3 weeks from cycle 3 until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
* The following treatment will be applied according to the newest edition of National Comprehensive Cancer Network (NCCN) guideline.

H101 15x10\^11vp intratumorally injection starts at day 1.

Camrelizumab will be administered at 200 mg i.v. every 3 weeks at day 2.

Camrelizumab

Ying Yang, MD

Guopei Luo, MD

The purpose of this study is to evaluate the efficacy of oncolytic virus plus PD-1 inhibitor to Patients with Advanced Pancreatic Cancer.

Pancreatic adenocarcinoma (PDAC) is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. In 2011, the PRODIGE trial has shown that oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) was associated with a survival advantage but had increased toxicity.

Recent studies have suggested that local destruction of tumor tissue by oncolytic virus induced activation and maturation of dendritic cells and tumor-specific T cells by cross-presentation of tumor antigens. PD-1 blocking antibody interferes with PD-1 mediated T-cell regulatory signaling. Combination of PD-1 blocking antibody plus oncolytic virus may increase anti-tumor efficacy in pancreatic cancer.

The purpose of this study is to evaluate the efficacy of oncolytic virus plus PD-1 inhibitor to patients with advanced pancreatic cancer who are refractory to standard chemotherapy. Progression-free survival (PFS), objective response rate (ORR), overall survival (OS) and disease control rate (DCR) are measured every three weeks.

Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer

OS of subjects from recruiting to the time of death from any cause

PFS of subjects from recruiting to the time of disease progression

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Uterine Cervical Neoplasms

Recurrence

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Recombinant human adenovirus type 5: one lesion was selected for intratumoral injection.Intratumoral injection of H101 was performed on day 1 and day 4 of each cycle, and was repeated once every 3 weeks. H101 dose:

① Tumor maximum diameter ≤5cm, 1.5×10\^12vp (3 injections) on day 1, 1.0×10\^12vp (2 injections) on day 4.

② Tumor maximum diameter \>5cm but ≤10cm, 3.0×10\^12vp (6 injections) on day 1 and 2.0×10\^12vp (4 injections) on day 4.

③ Tumor maximum diameter \>10cm, 4.5×10\^12vp (9 injections) on day 1 and 3.0×10\^12vp (6 injections) on day 4.

H101 intratumoral injection until the tumor is completely regressed to stop the drug, but not more than 5 cycles at most.

Camrelizumab: administered after H101 on day 1 of each cycle and repeated for 3 weeks. Camrelizumab dose: 200 mg IV.

Recombinant human adenovirus type 5: one lesion was selected for intratumoral injection.Intratumoral injection of H101 was performed on day 1 and day 4 of each cycle, and was repeated once every 3 weeks. H101 dose:

① Tumor maximum diameter ≤5cm, 1.5×1012vp (3 injections) on day 1, 1.0×1012vp (2 injections) on day 4.

② Tumor maximum diameter \>5cm but ≤10cm, 3.0×1012vp (6 injections) on day 1 and 2.0×1012vp (4 injections) on day 4.

③ Tumor maximum diameter \>10cm, 4.5×1012vp (9 injections) on day 1 and 3.0×1012vp (6 injections) on day 4.

H101 intratumoral injection until the tumor is completely regressed to stop the drug, but not more than 5 cycles at most.

Camrelizumab: administered after H101 on day 1 of each cycle and repeated for 3 weeks. Camrelizumab dose: 200 mg IV.

Recombinant human adenovirus type 5＋Camrelizumab

Xiang Zhang

There is no standard treatment for recurrent cervical cancer that progresses or persists after first-line treatment. The objective response rate of anti-PD-1 antibody treatment is about 15%. The purpose of this study was to evaluate whether the regimen could improve the objective response rate by intratumoral injection of oncolytic virus(recombinant human adenovirus type 5 injection, H101) combined with anti-PD-1 antibody(camrelizumab).

1. Main research purpose To evaluate the efficacy of H101 combined with camrelizumab in patients with incurable recurrent cervical cancer.
2. Secondary research purpose To evaluate other curative effects of H101 combined with camrelizumab in patients with incurable recurrent cervical cancer.

   To evaluate the safety of H101 combined with camrelizumab in patients with incurable recurrent cervical cancer.
3. Purpose of Exploratory Research To explore the changes of tumor microenvironment before and after H101 injection and the mechanism of action in combination with PD-1, and to accurately screen the beneficiaries based on molecular expression.
4. Overall experimental design This study is a multicenter, prospective, clinical study to investigate the efficacy and safety of H101 combined with camrelizumab in the treatment of incurable recurrent cervical cancer patients. It is expected that 55 subjects will be enrolled.

   The study was divided into 5 phases: screening period, baseline period, treatment period, and follow-up period. Patients with recurrent cervical cancer who were eligible for inclusion and were incurable by previous first-line treatment were screened. During the follow-up period, follow-up was conducted every 1 month for at least 2 years.
5. Subject population The target population of this study was patients with recurrent cervical squamous cell carcinoma/adenocarcinoma/adenosquamous carcinoma who were incurable after first-line therapy.
6. Treatment allocation All subjects enrolled in this study received H101 combined with camrelizumab.
7. Drug dosage and administration in the trial Dosing regimen: H101 + camrelizumab. 1) H101: 1 lesion was selected for intratumoral injection. Intratumoral injection of H101 was used on the 1st and 4th day of each cycle, repeated once in 3 weeks. H101 dosage: Tumor maximum diameter ≤5 cm, 1.5×10\^12vp (3 injections) on day 1 and 1.0×10\^12vp (2 injections) on day 4.

Tumor maximum diameter \>5cm but ≤10cm, 3.0×10\^12vp (6 injections) on day 1, 2.0×10\^12vp (4 injections) on day 4.

Tumor maximum diameter \>10cm, 4.5×10\^12vp (9 injections) on day 1 and 3.0×10\^12vp (6 injections) on day 4.

H101 will be used until injected lesion disappears or 5 cycles, whichever occurs first.

2) Camrelizumab: 200 mg intravenously. Dosing after H101 on day 1 of each cycle, repeated 3 weeks. The drug was discontinued or discontinued for 2 years until the patient developed tumor progression or intolerable toxicity.

H101 Combined With Camrelizumab for Recurrent Cervical Cancer

Oncolytic Virus(H101) Combined With Camrelizumab for Recurrent Cervical Cancer: a Prospective, Multicenter Study

The proportion of CR(complete response) and PR(partial response) in all patients.

Refers to the time from the first treatment day to the first occurrence of disease progression or death from any cause (whichever occurs first), and the end point event is determined by the investigator according to RECIST v1.1.

The proportion of CR(complete response), PR(partial response) and SD(stable disease) in all patients.

Time between the date of randomization grouping and death from any cause or the end of the last follow-up visit.

Zhejiang Cancer Hospital

Communicable Diseases

DNA Virus Infections

The experimental group was RFA combined H101.H101 has oncolysis in HCC after RFA and reduce tumor recurrence.

The standard control group was the conventional RFA.Using RFA for the treatment of small HCC.The efficacy was compared with that of the experimental group combined with H101.

Intraoperative injection of H101 can improve the efficacy of RFA in hepatocellular carcinoma.

Kai Feng, M.D

Kuansheng Ma, Ph.D

The primary reason for recurrence of hepatocellular carcinoma after radiofrequency ablation (RFA) is the micro-metastatic lesion that has not been ablated and inactivated in the transitional area.Some clinical trials have confirmed that H101(recombinant human adenovirus type 5 injection) has selective oncolysis in a variety of solid tumors.However, there are no reports that H101 which is injected during surgery can improve the efficacy of RFA in liver cancer at present.Therefore,We used a multicenter prospective randomized controlled study as the main method to prospectively compare the short-term and long-term efficacy of RFA combined with H101 group and traditional RFA group in the treatment of small liver cancer (single lesion , diameter less than or equal to 3cm，to evaluate the value of RFA combined with H101 injection in reducing the postoperative recurrence rate of small hepatocellular carcinoma, and to provide a reliable evidence-based medical basis for the selection of treatment methods for small hepatocellular carcinoma.

The primary reason for recurrence of hepatocellular carcinoma after radiofrequency ablation (RFA) is the micro-metastatic lesion that has not been ablated and inactivated in the transitional area.Oncolytic virus H101 is a genetically engineered adenovirus that lacks Elb 55ku protein.Some clinical trials have confirmed that H101 has selective oncolysis in a variety of solid tumors.Furthermore,research shows that the directly dissolving tumor activity of H101 enhanced obviously and activate the body's anti-tumor immune to induce the distal antitumor effect under the condition of mild high temperature (40 ℃ and 42 ℃).The transition zone of RFA can provide the appropriate mild high temperature.However, there are no reports that H101 which is injected during surgery can improve the efficacy of RFA in liver cancer at present.Therefore,We used a multicenter prospective randomized controlled study as the main method to prospectively compare the short-term and long-term efficacy of RFA combined with H101 group and traditional RFA group in the treatment of small liver cancer (single lesion , diameter less than or equal to 3cm，to evaluate the value of RFA combined with H101 injection in reducing the postoperative recurrence rate of small hepatocellular carcinoma, and to provide a reliable evidence-based medical basis for the selection of treatment methods for small hepatocellular carcinoma.

Radiofrequency Ablation Combined With Recombinant Human Adenovirus Type 5 in the Treatment of Hepatocellular Carcinoma.

Radiofrequency Ablation Combined With Local Injection of Recombinant Human Adenovirus Type 5 in the Treatment of Hepatocellular Carcinoma:A Multicenter Prospective Randomized Controlled Trial.

Postoperative tumor-free survival is an evaluation of tumor recurrence and metastasis.It's also an evaluation of the efficacy of the experimental group

The percentage of patients who receive certain treatments and are still alive after years of follow-up.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
HAIC Plus H101 vs HAIC Alone for Unresectable HCC at BCLC A-B	NCT03780049	Hepatocellular ...	HAIC of FOLFOX H101 Placebos	18 Years - 75 Years	Sun Yat-sen University
Oncolytic Virotherapy Plus PD-1 Inhibitor and Lenvatinib for Patients With Advanced Pancreatic Cancer	NCT05303090	Pancreatic Duct...	H101 Tislelizumab lenvatinib	18 Years -	Fudan University
Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer	NCT06196671	Pancreatic Canc...	H101 Camrelizumab	18 Years - 80 Years	Fudan University
H101 Combined With Camrelizumab for Recurrent Cervical Cancer	NCT05234905	Uterine Cervica... Oncolytic Virot... Camrelizumab	Recombinant hum...	18 Years - 80 Years	Zhejiang Cancer Hospital
Radiofrequency Ablation Combined With Recombinant Human Adenovirus Type 5 in the Treatment of Hepatocellular Carcinoma.	NCT03790059	Hepatocellular ...	H101 RFA	18 Years - 75 Years	Southwest Hospital, China
HAIC Plus H101 vs HAIC Alone for Unresectable HCC at BCLC A-B	NCT03780049	Hepatocellular ...	HAIC of FOLFOX H101 Placebos	18 Years - 75 Years	Sun Yat-sen University
Radiofrequency Ablation Combined With Recombinant Human Adenovirus Type 5 in the Treatment of Hepatocellular Carcinoma.	NCT03790059	Hepatocellular ...	H101 RFA	18 Years - 75 Years	Southwest Hospital, China
Oncolytic Virotherapy Plus PD-1 Inhibitor and Lenvatinib for Patients With Advanced Pancreatic Cancer	NCT05303090	Pancreatic Duct...	H101 Tislelizumab lenvatinib	18 Years -	Fudan University

Spots Global Cancer Trial Database for h101

Every month we try and update this database with for h101 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 h101

Every month we try and update this database with for h101 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 h101 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.