Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Esophageal Neoplasms

Recurrence

Disease Attributes

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Immunomodulating Agents

Oxaliplatin

Antimetabolites

Camrelizumab: 200mg,d1,15,29,43,57,I.V oxaliplatin：65mg/m2，d1，8，22, 29 capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total. radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.

placebo: 200mg,d1,15,29,43,57,I.V oxaliplatin：65mg/m2，d1，8，22, 29 capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total. radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.

Procedural death 1

Capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total.

radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.

Radiotherapy

Placebo

Shegan Gao, M.D,Ph.D

Tanyou Shan, M.D,M.S

Esophageal cancer is still a serious threat to human life and health. China in particular. Relapse and metastasis are important causes of treatment failure. Immunotherapy is a new treatment method, which can be used in combination with chemotherapy to improve the therapeutic effect. However, the role of immunotherapy combined with chemoradiotherapy in concurrent chemoradiotherapy of recurrent esophageal cancer has not been clearly studied. Our team will study it in detail.

The purpose of this study was to compare and analyze the effect of Camrelizumab in concurrent chemoradiotherapy of locally recurrent esophageal cancer.

In this study, patients with local recurrence of esophageal carcinoma without distant metastasis were randomly divided into experimental group and control group by Block randomization. In the experimental group, patients with local recurrence were treated with Camrelizumab combined with concurrent chemoradiotherapy. Followed up for 3 years to observe the objective remission rate and disease-free survival. In the control group, patients with local recurrence were treated with placebo combined with concurrent chemoradiotherapy. Followed up for 3 years to observe the objective remission rate and disease-free survival.

Clinical Control Study of Immunotherapy and Concurrent Chemoradiotherapy in Patients With Esophageal Cancer Recurrence

The Third Phase of Immunotherapy and Concurrent Chemoradiotherapy in Patients With Esophageal Cancer Recurrence Was Compared With the Clinical Comparison

rade 3/4 acute toxicities occurred during or within 90 days after CRT

Progression Free Survival After completion of the CRT

The First Affiliated Hospital of Henan University of Science and Technology

Carcinoma

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Immunologic Factors

Neoadjuvant Radiotherapy

Paclitaxel for Injection （Albumin Bound): 50mg/m\^2 QW Carboplatin: AUC=2 QW

Neoadjuvant Chemotherapy

Immunotherapy

Qixun Chen

Yongling Ji

Peng Ye

Qixun Chen, PhD

Yongling Ji, PhD

Weiyu Shen

To observe the 1-year disease-free survival rate （1-year PFS） of patients with resectable esophageal squamous cell carcinoma who received neoadjuvant chemoradiotherapy combined with camrelizumab and achieved clinical complete remission with watchful waiting strategy.

This trial is a prospective, multicenter, randomized controlled phase II clinical study.

Eligible patients with thoracic esophageal squamous cell carcinoma in clinical stage cT2-4aNanyM0, or cT1-3N+M0. The patient received radiotherapy (41.4Gy/23F), chemotherapy (nab-paclitaxel combined with carboplatin), immunotherapy (Camrelizumab), and a combination of imaging, endoscopy and biopsy pathology was performed 4-6 weeks after the end of neoadjuvant therapy.

Evaluate (CRE1) to determine whether clinical complete resection (cCR) has been achieved. If clinical complete resection is not reached, patients will receive radical surgery; For subjects who have achieved clinical complete resection（cCR）, they will be randomly divided into an operation group and an observational waiting group. After 14 weeks, the combined imaging, endoscopy and biopsy pathological evaluation (CRE2) was performed again to determine whether the clinical complete resection (CCR2) was reached. If the patient has local progression and can be resected, radical surgery will be performed; if there is distant progression, medical oncology treatment or supportive treatment will be performed; if clinical complete resection remains, continuous and close imaging, endoscopic and Biopsy pathology combined evaluation (CRE3-14). After achieving clinical complete resection, patients who continue to be followed up for observation or undergo radical surgery, if there is no contraindication to treatment, receive 14 cycles of Camrelizumab maintenance therapy. During follow-up stage, if the patient develops local progression and can be resected, radical surgery is performed; if distant progression occurs, medical oncology treatment or supportive treatment is performed; if clinical complete remission is still achieved, follow-up evaluation can be continued. Among them, the 1-year disease-free survival rate under the esophagus-sparing treatment strategy after achieving clinical complete remission was the main endpoint of the study.

To observe the disease-free survival（DFS）, overall survival（OS）, event-free survival（EFS）, quality of life（QoL）, failure mode and choice of post-failure treatment mode after neoadjuvant chemoradiotherapy combined with Camrelizumab therapy or after surgical resection. And, the pathological complete remission rate and the main pathological resection rate of the patients who underwent surgery.

The blood, stool and tissue samples of patients participating in the trial will be retained for future detection of relevant markers and related laboratory research.

Treatment safety and toxicity, including acute and chronic toxicity, will be evaluated on an ongoing basis during treatment and follow-up.

Any serious adverse drug reactions will be promptly reported to the hospital ethics committee.

The relationship between relevant markers and clinical outcomes will be analyzed.

Watch and Wait for NeoAdjuvant Concurrent Radiochemotherapy Combined With Camrelizumab in Patients With Resectable ESCC

Watch and Wait for NeoAdjuvant Concurrent Radiochemotherapy Combined With Camrelizumab in Patients With Resectable Esophageal Squamous Cell Carcinoma，A Prospective, Single-Center, Open Label，Phase II Cohort Study （WATCHER）

Jiangsu HengRui Medicine Co., Ltd.

Zhejiang Cancer Hospital

Director

Urinary Tract, Sexual Organs, and Pregnancy 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

Cisplatin

External beam radiotherapy:

Pelvic and para-aortic radiotherapy 45-50.4Gy/25-28 fractions. PET-CT positive lymph node should be boost to a dose of 60Gy or higher. Parametrium(both) should be boost to a dose from 50Gy to 60Gy.

Concurrent chemotherapy:

Weekly cisplatin 40mg/m2 during external beam radiotherapy.

Brachytherapy:

High dose rate(HDR) Brachytherapy. The dose of high-risk clinical target volume(HR CTV) D90 or Point A should be 85Gy+/-10%. The dose of intermediate-risk clinical target volume(IR CTV) D98 should be 60Gy at least.

External beam radiotherapy:

Pelvic radiotherapy 45-50.4Gy/25-28 fractions. PET-CT positive lymph node should be boost to a dose of 60Gy or higher. Parametrium(both) should be boost to a dose from 50Gy to 60Gy.

Concurrent chemotherapy:

Weekly cisplatin 40mg/m2 during external beam radiotherapy.

Brachytherapy:

HDR Brachytherapy. The dose of HR CTV D90 or Point A should be 85Gy+/-10%. The dose of IR CTV D98 should be 60Gy at least.

The para-aortic area, from left renal vein level to abdominal aorta bifurcation level，will be prophylactic irradiation. The other intervention is the same as control arm.

Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiation

Pelvic definitive concurrent chemoradiation, including external beam radiotherapy, concurrent chemotherapy and brachytherapy.

Pelvic definitive concurrent chemoradiation

Xiang Zhang

Jianhong Chen

Yeqiang Tu

Para-aortic lymph node metastasis is a poor prognostic factor for locally advanced cervical cancer, but false negative diagnosis is easy to occur. The aim of this trial was to investigate whether para-aortic prophylactic radiotherapy improves disease-free survival in patients with positive pelvic lymph nodes below the common iliac artery.

This clinical trial enrolled participants with locally advanced cervical cancer with positive pelvic lymph nodes below the common iliac region diagnosed by Positron emission tomography-computed tomography(PET-CT). Participants should be able to receive concurrent cisplatin chemotherapy. No anti-tumor treatment was given before randomization. Participants will be randomly assigned to two groups. The study group will receive radiotherapy of pelvic and para-aorta, concurrent chemotherapy and brachytherapy, and the control group will receive pelvic radiotherapy, concurrent chemotherapy and brachytherapy.

Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer

Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer: a Prospective, Randomized, Multicenter Study

the percentage of participants in the group whose disease is likely to remain stable

the percentage of participants in the group who survives

the percentage of participants involved by recurrence in the area of para-aortic lymph node

the percentage of participants involved by recurrence in any organ or tissue except pelvic and para-aortic area

an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns (assessed by EORTC QLQ-C30 v3 )

an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns (assessed by EORTC QLQ-CX24)

Respiratory Tract (Lung and Bronchial) Diseases

Small Cell Lung Carcinoma

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Small Cell Lung Cancer

Etoposide

Etoposide phosphate

Enzyme Inhibitors

Participants receive etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab（ PD-L1 inhibitor）1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.

Etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab（ PD-L1 inhibitor）1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.

Adebrelimab

Radiation Therapy

etoposide, carboplatin(EC)

Qimig Wang, Doctor

Qiming Wang, Doctor

Guangyuan Hu, Doctor

Patients with extensive-stage small-cell lung cancer (ES-SCLC) have poor prognosis, with limited treatment options. Chemo-immunotherapy is the standard 1st-line therapy for patients with ES-SCLC.When 4 cycles of etoposide+carboplatin (EC) or etoposide+cisplatin(EP) chemotherapy combined with PD-L1 inhibitor are effective, guidelines recommend additional thoracic radiotherapy.

In this study, the investigators bring radiotherapy forward, which means that after 2 cycles of EC chemotherapy plus Adebrelimab, participants with response（PR/CR/SD）will receive concurrent radiotherapy and 2 cycles of EC chemotherapy plus Adebrelimab, then maintenance therapy with Adebrelimab （Q3W）.

The purpose of this study is to explore the safety and efficacy of Adebrelimab combined with concurrent chemoradiotherapy in untreated participants with extensive-stage small cell lung cancer.

Participants receive EC chemotherapy combined with Adebrelimab for 2 cycles, and the efficacy will be evaluated. If the efficacy evaluation is SD/PR/CR, concurrent chemoradiotherapy combined with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy + Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.

Adebrelimab and Concurrent Radiochemotherapy as First-line Treatment for Extensive-stage Small-cell Lung Cancer

6-m PFS rate is defined as the percentage of participants whose disease is still progression-free at the 6th month

Objective response rate is defined as the proportion of subjects who have a CR or a PR

Progression-free survival is defined as the time from the first treatment to the first documented disease progression

Overall survival is defined as the time from the first treatment to death due to any cause.

12-m PFS rate is defined as the percentage of participants whose disease is still progression-free at the 12th month

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Control Study of Immunotherapy and Concurrent Chemoradiotherapy in Patients With Esophageal Cancer Recurrence	NCT04404491	Esophageal Mali...	Procedural deat... Capecitabine Radiotherapy Placebo	18 Years - 75 Years	The First Affiliated Hospital of Henan University of Science and Technology
Watch and Wait for NeoAdjuvant Concurrent Radiochemotherapy Combined With Camrelizumab in Patients With Resectable ESCC	NCT05507411	Esophageal Squa...	Neoadjuvant Rad... Neoadjuvant Che... Immunotherapy	18 Years - 75 Years	Zhejiang Cancer Hospital
Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer	NCT04974346	Cervical Cancer	Paraaortic prop... Pelvic definiti...	18 Years - 75 Years	Zhejiang Cancer Hospital
Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer	NCT04974346	Cervical Cancer	Paraaortic prop... Pelvic definiti...	18 Years - 75 Years	Zhejiang Cancer Hospital
Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer	NCT04974346	Cervical Cancer	Paraaortic prop... Pelvic definiti...	18 Years - 75 Years	Zhejiang Cancer Hospital
Adebrelimab and Concurrent Radiochemotherapy as First-line Treatment for Extensive-stage Small-cell Lung Cancer	NCT06236997	Small Cell Lung...	Adebrelimab Radiation Thera... etoposide, carb...	18 Years - 75 Years	Henan Cancer Hospital

Spots Global Cancer Trial Database for concurrent radiochemotherapy