Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Radiotherapy (Total dose: 18\~22 Gy; Single dose: 18\~22 Gy; Frequency: 1) + Sequential chemotherapy

Three dimensional conformal radiation therapy (3D-CRT) (Total dose: 60 Gy; Single dose: 2 Gy; Frequency: 30) + Concurrent chemotherapy (Gemcitabine(GEM), 800 mg/m2 weekly on Day 1-21, Q28d; or S-1 orally, 400 mg/d, bid on Day 1-21, Q28d) + Sequential chemotherapy

Total dose: 18\~22 Gy; Single dose: 18\~22 Gy; Frequency: 1

Intraoperative radiotherapy (IORT)

Sequential chemotherapy

Total dose: 60 Gy; Single dose: 2 Gy; Frequency: 30

Three dimensional conformal radiation therapy (3D-CRT)

Gemcitabine (GEM), 800 mg/m2 weekly on Day 1-21, Q28d; or S-1 orally, 400 mg/d, bid on Day 1-21, Q28d

Concurrent chemotherapy

Jianwei Zhang, Ph.D.

Shuisheng Zhang, M.D.

Chengfeng Wang, B.A.

The purpose of this study is to find the better radiation therapy between intraoperative radiotherapy (IORT) and concurrent chemoradiotherapy (CCRT).

The trial is funded by National High-tech R\&D Program (863 Program). The trial is prepared to be registered on the clinicaltrail.gov.

Quality assurance plan: Every participant is enrolled or excluded by two practiced investigators. And two investigators participated in all steps of the trail, including the record of the data, and the investigators will compare the data. If the data is consistent, the investigators would record the data; if not, the data would be checked and decided by the two investigators. All the steps and data are site monitored and audited by the workers of research and financial department of The First Affiliated Hospital of China Medical University Data check: The investigators compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry. Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources, including medical records and electronic case report forms. Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information, and normal ranges if relevant. Standard Operating Procedures to address registry operations and analysis activities, such as participants recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. All registry operations would be done according to specific steps, and by two practiced investigators. Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect. According to the formula to differ advantages and disadvantages, the investigators need at least 100 participants to take part in the trail. The investigators can recruit about 120 participants every year according to previous experiences, so the investigators should recruit at least for one years.

Plan for missing data: The investigators would collect as much data as possible, and the investigators exclude the participants who cannot cooperate on recruitment. And the investigators manage situations according to statistical principles where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results.

Statistical analysis plan: Kaplan-Meier method would be used to analyze the difference of survival time between the two groups, and the local control rate of the two groups would be compared by chi square test. Statistical analyses would be performed by using IBM SPSS Statistics(version 20; IBM, Chicago, USA). The level of significance is defined as P \< 0.05.

IORT Versus CCRT for Pancreatic Cancer

Intraoperative Radiotherapy (IORT) Versus Concurrent Chemoradiotherapy (CCRT) for Pancreatic Cancer

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Director of Department of Abdominal Surgical Oncolgoy

Respiratory Tract (Lung and Bronchial) Diseases

Behaviors and Mental Disorders

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Quality of Life

Etoposide

Cisplatin

Etoposide phosphate

Endostar protein

Endostatins

Angiogenesis Inhibitors

Growth Inhibitors

Chemotherapy: Cisplatin (50 mg/m2) on days 1, 8, 29, and 36 and etoposide (50mg/m2) on days 1～5 and 29～33.

Radiotherapy: Thoracic radiotherapy (TRT) started with a linear accelerator (6MV-X) on the first day of chemotherapy.A minimum dose of 60 Gy (2 Gy per fraction, Monday～Friday) was delivered, and a range of 60-66 Gy in 2 Gy fractions was allowed.

Endostar(15 mg/m2) was durative transfused every 24 hours for 5 days during the normalization window of the first chemoradiotherapy cycle(days -5～-1).

Chemotherapy: Cisplatin (50 mg/m2) on days 1, 8, 29, and 36 and etoposide (50mg/m2) on days 1～5 and 29～33.

Radiotherapy: Thoracic radiotherapy (TRT) started with a linear accelerator (6MV-X) on the first day of chemotherapy.A minimum dose of 60 Gy (2 Gy per fraction, Monday～Friday) was delivered, and a range of 60-66 Gy in 2 Gy fractions was allowed.

Endostar(15 mg/m2) was durative transfused every 24 hours for 5 days during the normalization window of the first and the second chemoradiotherapy cycles(days -5～-1 and 24～28).

Chemotherapy: Cisplatin (50 mg/m2) on days 1, 8, 29, and 36 and etoposide (50mg/m2) on days 1～5 and 29～33.

Radiotherapy: Thoracic radiotherapy (TRT) started with a linear accelerator (6MV-X) on the first day of chemotherapy.A minimum dose of 60 Gy (2 Gy per fraction, Monday～Friday) was delivered, and a range of 60-66 Gy in 2 Gy fractions was allowed.

concurrent chemoradiotherapy (CCRT)

Endostar(15mg/m2) was durative transfused during the normalization window of the first chemoradiotherapy cycle(days -5～-1).

Endostar for one cycle

Endostar(15mg/m2) was durative transfused during the normalization window of the first and the second chemoradiotherapy cycles(days -5～-1 and 24～28).

Endostar for two cycles

Daiyuan Ma, M.D

xin hu, M.D

xiangdong fang, M.D

To investigate the safety and efficacy recombinant human endostatin(endostar) durative transfusion combined with cocurrent chemoradiotherapy in advanced non-small cell lung cancer(NSCLC).

Patients were randomly assigned to a regimen of W1-CCRT(one treatment cycle of intravenous pump of recombinant human endostatin before chemoradiotherapy), or W2-CCRT(two treatment cycle of intravenous pump of recombinant human endostatin before chemoradiotherapy), or CCRT.

Endostar in Combination With Chemoradiotherapy in Patient With Advanced Non-small Cell Lung Cancer

Recombinant Human Endostatin (Endostar) Combined With Concurrent Chemoradiotherapy for Advanced Non-small Cell Lung Cancer: A Multicenter, Randomized, Controlled Trial

Evaluate the effect of chemoradiotherapy with or without recombinant human endostatin on progression free survival

comparison to maintenance chemoradiotherapy alone

Toxicity and adverse events related to the inventions

Jiangsu Simcere Pharmaceutical Co., Ltd.

Afﬁliated Hospital of North Sichuan Medical College

Director of Cancer Center

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antibodies

Antibodies, Monoclonal

Paclitaxel

Carboplatin

Tislelizumab

Albumin-Bound Paclitaxel

Immunoglobulins

Antineoplastic Agents, Immunological

Tislelizumab 200 mg is administered by intravenous (IV) administration and given together upfront with concurrent platinum-based chemoradiotherapy (cCRT) for the first 6 weeks, followed by tislelizumab 200 mg by IV adminstration monotherapy. The standard platinum-based chemotherapy options include carboplatin/ paclitaxel and cisplatin/etoposide

Placebo is given with concurrent platinum-based chemoradiotherapy (cCRT) for the first 6 weeks, followed by tislelizumab 200 mg by IV administration monotherapy. The standard platinum-based chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide.

Placebo is given with concurrent platinum-based chemoradiotherapy (cCRT) for the first 6 weeks, followed by placebo monotherapy. The standard platinum-based chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide.

PD-1 inhibitor (monoclonal antibody against PD-1)

Chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide per standard of care. Radiotherapy will also be given concurrently with chemotherapy.

Concurrent chemoradiotherapy (cCRT)

Placebo

Marie Nguyen, MD

This is a Phase 3, randomized, double-blind, placebo-controlled multicenter global study designed to compare the efficacy and safety of tislelizumab in combination with concurrent chemoradiotherapy (cCRT) followed by tislelizumab monotherapy versus cCRT alone, and tislelizumab given sequentially after cCRT versus cCRT alone, in newly diagnosed stage III subjects with locally advanced, unresectable non-small cell lung cancer (NSCLC). The primary endpoint is centrally-assessed progression free survival (PFS) in the intent-to-treat (ITT) population. .

A Study of Tislelizumab (BGB-A317) Plus Chemoradiotherapy Followed by Tislelizumab Monotherapy in Newly Diagnosed, Stage III Subjects With Locally Advanced, Unresectable Non-small Cell Lung Cancer

A PHASE 3, RANDOMIZED, BLINDED, PLACEBO-CONTROLLED STUDY OF TISLELIZUMAB (BGB-A317) PLUS CHEMORADIOTHERAPY FOLLOWED BY TISLELIZUMAB MONOTHERAPY IN NEWLY DIAGNOSED, STAGE III SUBJECTS WITH LOCALLY ADVANCED, UNRESECTABLE NON-SMALL CELL LUNG CANCER

Progression-free survival was defined as the time from the date of randomization to the date of the first objectively tumor progression as assessed by the blinded independent central review per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred first. Stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for Progressive disease (PD)• Progressive Disease- At least a 20% increase in the sum of diameters of target lesions from nadir.

Overall survival was defined as the time between randomization of treatment and death from any cause.

Overall Response was defined as percentage of participants who had a radiologic confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines, between Day 1 of treatment and subsequent anti-cancer therapy, death or study discontinuation. Complete response was defined as the disappearance of all target lesions; partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions from baseline; stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease (PD).

Duration of Response is defined as the time from the first occurrence of a documented objective response to the time of relapse, as determined by blinded independent central review per RECIST v1.1, or death from any cause, whichever comes first.

Progression-free survival was defined as the time from the date of randomization to the date of the first objectively tumor progression as assessed by the blinded independent central review per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred first

TTDM was defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis was defined as any new lesion that is outside of the radiation field according to RECIST v1.1 or proven by biopsy.

TEAEs include any adverse events (AEs) that had an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of new anticancer therapy, whichever occurred first. TEAEs also included all immune-related AEs recorded up to 90 days after the last dose of tislelizumab or placebo, regardless of whether or not the particpant started a new anticancer therapy. In addition, any serious AE with an onset date more than 30 days after the last dose of study drug that is assessed by the investigator as related to study drug were considered a TEAE."

The EORTC QLQ-C30 is a 30-item, questionnaire assessing quality of life (QoL), psychosocial burden and physical symptoms. It is classified into 15 domains: 5 functional subscales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning); 3 multi-item symptom subscales (fatigue, nausea/vomiting, and pain); each item is measured on a 4 point response scale; (not at all, a little, quite a bit, very much), with the exception of the 2 items measuring global health and QoL, (measured on a 7-point response scale). Scores are linearly transformed to 0 to 100 scores. Scores vary from 0 (worst) to 100 (best) for the functional dimensions and GHS, and from 0 (best) to 100 (worst) for the symptom dimensions; higher scores = better QoL, better functioning, or more severe symptoms, respectively. The LC13 covers 13 typical symptoms of lung cancer patients, such as coughing, pain, dyspnea, sore mouth, peripheral neuropathy, and hair loss.

Included the percentage of participants who would have received at least one dose of tislelizumab or placebo in the monotherapy phase before progression.

BeiGene

Celgene

No serious adverse events or deaths occurred during the course of the study,

Participants were to receive 2 cycles of tislelizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) with concurrent chemoradiotherapy (cCRT), followed by monotherapy with tislelizumab 200 mg IV Q3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.

Tislelizumab + Concurrent Chemoradiotherapy -Tislelizumab

Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with tislelizumab 200 mg IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.

Placebo + Concurrent Chemoradiotherapy -Tislelizumab

Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.

Placebo + Concurrent Chemoradiotherapy - Placebo

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race/Ethnicity, Customized

Intent to Treat Population included all randomized participants regardless of whether the participant received any study drug or had any efficacy assessments performed.

Anne McClain

The study was terminated. The number of participants and the data collection period were not sufficient for statistical analysis. The patient withdrew consent.

Progression-Free Survival (PFS)

Overall Survival (OS)

Overall Survival at 24 Months

Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response

Duration of Response

Percentage of Participants Alive and Progression-Free at 12 Months (APF12)

Percentage of Participants Alive and Progression-free at 18 Months (APF18)

Time to Distant Metastasis (TTDM)

≥ 1 TEAE

≥ 1 Treatment Related TEAE

Safety population includes participants who received at least 1 dose of study drug.

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Number of Participants With Lung Cancer Symptoms Assessed by the Corresponding Domains of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30) and Lung-Cancer Specific QLQ-LC13

Percentage of Participants Who Would Have Continued on to Monotherapy Phase

Overall Study

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Nasopharyngeal Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Capecitabine

Antimetabolites

EBV DNA ≥4000 copies/mL OR N3 OR T4N+ (TNM AJCC/UICC 8th edition) AND EBV DNA detectable after 3 cycles of IC.

CCRT: Radiotherapy will be delivered once daily, for 5 days per week, over 6 to 7 weeks. During RT, cisplatin will be administered either 100 mg/m2 3-weekly or 40 mg/m2 weekly, IV infusion (physician's choice).

Maintenance: Tislelizumab 200mg, day 1 per 3-week cycle, intravenous (IV) infusion and capecitabine 650 mg/m2, days 1-21 per 3-week cycle, bidaily, oral, for a total of 12 months (17 cycles).

CCRT with Maintenance Tislelizumab and Metronomic Capecitabine

Melvin LK CHUA, MBBS, FRCR, PhD, FAMS

Enya HW ONG

Patients with "high-risk" locoregionally-advanced nasopharyngeal carcinoma (LA-NPC), defined as AJCC/UICC 8th edition TNM-stage III-IVA and high Epstein-Barr virus (EBV) DNA viral load (≥4,000 copies/mL) will require induction chemotherapy (IC) prior to chemo-radiation (CCRT) as per standard treatment. Patients who persist to manifest DETECTABLE EBV DNA following 3 cycles of IC have a higher risk of relapse, and are typically recommended for a year of low-dose oral chemotherapy after CCRT.

RIBBON-LA-01 is a single-arm, open-label, phase 2 clinical trial of maintenance tislelizumab and metronomic capecitabine (metroCap) for 52 weeks after IC and CCRT, targeting this specific group of patients who have persistent detectable EBV DNA after IC. The main objective is to evaluate the efficacy of maintenance tislelizumab and metroCap in patients with DETECTABLE EBV DNA levels after 3 cycles of IC.

RIBBON-LA-01 is embedded in a modular platform trial concept (NCT05517135, https://clinicaltrials.gov/study/NCT05517135) that tests if EBV DNA-based risk stratification strategies for treatment individualization improves survival outcomes in LA-NPC. The overarching platform trial concept allocates patients with LA-NPC to treatment arms of different intensities by their plasma EBV DNA levels pre-treatment and post-IC.

RIBBON-LA-01 enrolls patients allocated to Arm 3 of the platform trial; these are patients with pre-treatment EBV DNA of \>4,000 copies/mL OR N2-3 or T4N+ NPC who were treated with upfront IC, but persist to manifest DETECTABLE EBV DNA levels following 3 cycles of IC. Patients on the trial will be assigned to CCRT followed by a 12-month course of maintenance tislelizumab and metroCap.

The primary endpoint of the study is two-year disease free survival, defined as the proportion of patients who are alive and free of disease relapse at the end of 2 years after the start of treatment.

Tislelizumab and Metronomic Capecitabine as Maintenance in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma

RIBBON-LA-01: Single-arm, Open-label, Phase 2 Trial of Tislelizumab and Metronomic Capecitabine as Maintenance Therapy in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma

The proportion of patients who are alive and free of disease relapse at the end of 2 years after the start of Induction Chemotherapy (IC) for patients.

Time from date of start of treatment (IC) to death from any cause, where patients lost to follow-up were censored at the date of last follow-up.

Time from date of start of treatment (IC) to documented distant metastasis or death from any cause, patients with locoregional relapse as a first event will be censored at date of locoregional relapse

Time from date start of treatment (IC) to documented locoregional relapse or death from any cause, patients with distant metastasis as a first event will be censored at the date of distant metastasis

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
IORT Versus CCRT for Pancreatic Cancer	NCT02981641	Pancreatic Canc...	Intraoperative ... Sequential chem... Three dimension... Concurrent chem...	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IORT Versus CCRT for Pancreatic Cancer	NCT02981641	Pancreatic Canc...	Intraoperative ... Sequential chem... Three dimension... Concurrent chem...	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Endostar in Combination With Chemoradiotherapy in Patient With Advanced Non-small Cell Lung Cancer	NCT03588494	Quality of Life	concurrent chem... Endostar for on... Endostar for tw...	18 Years - 70 Years	Afﬁliated Hospital of North Sichuan Medical College
A Study of Tislelizumab (BGB-A317) Plus Chemoradiotherapy Followed by Tislelizumab Monotherapy in Newly Diagnosed, Stage III Subjects With Locally Advanced, Unresectable Non-small Cell Lung Cancer	NCT03745222	Carcinoma, Non-...	Tislelizumab Concurrent chem... Placebo	18 Years -	Celgene
A Study of Tislelizumab (BGB-A317) Plus Chemoradiotherapy Followed by Tislelizumab Monotherapy in Newly Diagnosed, Stage III Subjects With Locally Advanced, Unresectable Non-small Cell Lung Cancer	NCT03745222	Carcinoma, Non-...	Tislelizumab Concurrent chem... Placebo	18 Years -	Celgene
Tislelizumab and Metronomic Capecitabine as Maintenance in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma	NCT06093061	Nasopharyngeal ...	CCRT with Maint...	21 Years - 99 Years	National Cancer Centre, Singapore
Tislelizumab and Metronomic Capecitabine as Maintenance in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma	NCT06093061	Nasopharyngeal ...	CCRT with Maint...	21 Years - 99 Years	National Cancer Centre, Singapore
A Study of Tislelizumab (BGB-A317) Plus Chemoradiotherapy Followed by Tislelizumab Monotherapy in Newly Diagnosed, Stage III Subjects With Locally Advanced, Unresectable Non-small Cell Lung Cancer	NCT03745222	Carcinoma, Non-...	Tislelizumab Concurrent chem... Placebo	18 Years -	Celgene

Spots Global Cancer Trial Database for concurrent chemoradiotherapy (ccrt)