Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

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

Participants receive candonilimab at a dose of 10 mg/kg, Q3W (Day 1 of each 21 day treatment cycle) via IV infusion, until disease progression, intolerable toxicity, investigator determines that the participant cannot continue to benefit, withdraws informed consent, or candonilimab treatment over 2 years. During the q3w dosing period of candonilimab, participants receive radiotherapy including external beam radiotherapy (EBRT) and followed by brachytherapy.

Candonilimab（AK104）

EBRT

Xingtao Long, MD

Qi Zhou, PhD

Qi Zhou, MD

Candonilimab（AK104）is a humanized IgG1 bispecific antibody that targets PD-1 and CTLA-4.

This is a single-arm, multicenter, open-label, phase II study, the purpose of this study is to evaluate the efficacy and safety of candonilimab plus radiotherapy in participants with locally advanced cervical cancer who do not tolerate chemotherapy.

Study Of Candonilimab Combined With Radiotherapy In The Treatment of Locally Advanced Cervical Cancer

A Single-arm, Multicenter, Phase II Study to Evaluate Candonilimab（AK104） Combined With Radiotherapy For The Treatment of Locally Advanced Cervical Cancer

The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1.

The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.

Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first.

OS is the time from randomization to death due to any cause

The EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. The change from baseline in EORTC QLQ-C30 score will be presented.

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

Akeso Pharmaceuticals, Inc.

Chongqing University Cancer Hospital

Professor

Symptoms and General Pathology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Neoplasm Metastasis

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

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Cisplatin

Antimetabolites

IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy

IMRT combine with cisplatin concurrent chemotherapy

Patients in the control arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1 and day 22) during RT.

Patients in the experimental arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1 and day 22) during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles at 4 weeks later after RT.

zhao chong, M.D

This is a randomized,controlled,prospective phase III clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.Exploring an Individualized comprehensive treatment plan which is reasonable,effective,low toxicity and fitting with Modern radiotherapy techniques for Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.

Prognostic Analysis of Concurrent Chemoradiotherapy With/Without Adjuvant Chemotherapy for Locally Advanced NPC Patients

Randomized Trial of Concurrent Cisplatin Chemoradiotherapy Plus Capecitabine Adjuvant Chemotherapy vs Concurrent Cisplatin Chemoradiotherapy Alone for Patients With Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis

Defined as the time from date of recruitment to documented distant metastasis or death from any cause.

Defined as the time from date of recruitment to documented relapse or death from any cause.

Defined as the time from date of recruitment to documented locoregional relapse or death from any cause.

Defined as the time from date of recruitment to death from any cause.

Acute toxicities were graded using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0) for chemotherapy-specific toxicities, and the Radiation Therapy Oncology Group (RTOG) radiation morbidity scoring criteria for radiotherapy-specific toxicities.

Late toxicities were assessed annually using the RTOG radiation morbidity scoring criteria.

Sun Yat-sen University

Immune Checkpoint Inhibitors

Participants receive envafolimab 150 mg subcutaneously (SC) on Day 1 of each week cycle (QW) for 8 cycles followed by envafolimab 300 mg SC on Day 1 of each 3-week cycle (Q3W) until disease progression, intolerable toxicity, investigator determines that the participant cannot continue to benefit, withdraws informed consent, or envafolimab treatment over 2 years. During the QW dosing period of envafolimab, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 45 Gray Units (Gy)with the total duration of radiation treatment not to exceed 56 days.

Envafolimab

External Beam Radiotherapy (EBRT)

Performed according to clinically required dose

Brachytherapy (BT)

This is a single-arm, single-center, exploratory study, the purpose of this study is to evaluate the efficacy and safety of envafolimab combined with Chemoradiotherapy in participants with locally advanced cervical cancer.

Study of Chemoradiotherapy With Envafolimab For The Treatment of Locally Advanced Cervical Cancer

A Single-arm Exploratory Clinical Study of Envafolimab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer

PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at Month 24 using the entire PFS data up to the cut-off date.

The DoR is defined as the time from first response to disease progression or death in the absence of disease progression. First response was defined as first CR or PR was achieved. DoR will be summarized for responding patients and DoR rates (%) at 12, 24, and 36 months will be provided.

PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at Month 12/36 using the entire PFS data up to the cut-off date.

OS is the time from randomization to death due to any cause. OS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the OS rate at Month 12/24/36 using the entire OS data up to the cut-off date.

The EORTC QLQ-CX24 is a questionnaire that rates the symptoms common to women with cervical cancer and evaluates the impact of disease and/or treatments. The 24 items use a 4-point scale (1=not at all to 4=very much) and are classified into 3 multi-item scales, 11 items with symptom experience, 3 items with body image, and 4 items with sexual/ vaginal functioning. The other items of the questionnaire are lymphedema, peripheral neuropathy, menopausal symptom, sexual worry, sexual activity, and sexual enjoyment. The change from baseline in EORTC QLQ-CX24 score will be presented.

Patients in the control arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT.

Patients in the experimental arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles.

This is an randomized controlled, multicenter clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in local advanced high risk nasopharyngeal carcinoma.

Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial

Defined as the time from date of recruitment to documented distant metastatic recurrence or death from any cause.

To evaluate the late toxicity with the RTOG/EORTC criterion when concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy is used.

To evaluate the acute toxicity with CTC 3.0 when concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy is used.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study Of Candonilimab Combined With Radiotherapy In The Treatment of Locally Advanced Cervical Cancer	NCT05687851	Locally Advance...	Candonilimab（AK... EBRT BT	18 Years -	Chongqing University Cancer Hospital
Prognostic Analysis of Concurrent Chemoradiotherapy With/Without Adjuvant Chemotherapy for Locally Advanced NPC Patients	NCT02973386	Local Advanced ...	IMRT combine wi... IMRT combine wi...	18 Years - 70 Years	Sun Yat-sen University
Study of Chemoradiotherapy With Envafolimab For The Treatment of Locally Advanced Cervical Cancer	NCT05799469	Locally Advance...	Envafolimab Cisplatin External Beam R... Brachytherapy (...	18 Years - 75 Years	Chongqing University Cancer Hospital
Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial	NCT02143388	Local Advanced ...	IMRT combine wi... IMRT combine wi...	18 Years - 70 Years	Sun Yat-sen University
Study Of Candonilimab Combined With Radiotherapy In The Treatment of Locally Advanced Cervical Cancer	NCT05687851	Locally Advance...	Candonilimab（AK... EBRT BT	18 Years -	Chongqing University Cancer Hospital
Prognostic Analysis of Concurrent Chemoradiotherapy With/Without Adjuvant Chemotherapy for Locally Advanced NPC Patients	NCT02973386	Local Advanced ...	IMRT combine wi... IMRT combine wi...	18 Years - 70 Years	Sun Yat-sen University

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