Neoplasms

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

All Conditions

Rare Diseases

Nasopharyngeal Carcinoma

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

Gemcitabine

Bevacizumab

Cisplatin

Immunomodulating Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Patients will receive induction therapy with toripalimab plus bevacizumab and gemcitabine every 3 weeks for 3 cycles before radiotherapy, then followed by IMRT and concurrent therapy with toripalimab plus bevacizumab for 2 cycles, then followed by adjuvant therapy with toripalimab every 3 weeks for a maximum of 1 year after radiotherapy.

Patients will receive induction therapy with toripalimab plus bevacizumab and gemcitabine every 3 weeks for 3 cycles before radiotherapy, then followed by IMRT and concurrent therapy with toripalimab plus bevacizumab for 2 cycles, then followed by adjuvant therapy with toripalimab and bevacizumab every 3 weeks for a maximum of 1 year after radiotherapy.

Induction therapy:

Toripalimab (240mg iv drip)+Bevacizumab (7.5mg/kg iv drip)+gemcitabine (1,000 mg/m2), every 3 weeks for 3 cycles before radiotherapy.

Concurrent therapy:

Toripalimab (240mg iv drip)+Bevacizumab (7.5mg/kg iv drip), every 3 weeks for 2 cycles during radiotherapy.

Adjuvant therapy:

Toripalimab (240mg iv drip)+Bevacizumab (7.5mg/kg iv drip), every 3 weeks for 1 year after radiotherapy.

Radiation:

Intensity-modulated radiotherapy.

Bevacizumab+Toripalimab+gemcitabine, adjuvant with Bevacizumab and Toripalimab

Induction therapy:

Toripalimab (240mg iv drip)+Bevacizumab (7.5mg/kg iv drip)+gemcitabine (1,000 mg/m2), every 3 weeks for 3 cycles before radiotherapy.

Concurrent therapy:

Toripalimab (240mg iv drip)+Bevacizumab (7.5mg/kg iv drip), every 3 weeks for 2 cycles during radiotherapy.

Adjuvant therapy:

Toripalimab (240mg iv drip), every 3 weeks for 1 year after radiotherapy.

Radiation:

Intensity-modulated radiotherapy.

Bevacizumab+Toripalimab+gemcitabine, adjuvant with Toripalimab

Ming-Yuan Chen, MD, PhD

Xi Ding, MD

Ming-Yuan Chen, MD,PhD

Ming-yuan Chen, MD, PhD

At present, the treatment regimen of locally advanced nasopharyngeal carcinoma still needs to be further improved, and the focus of improvement lies in "replacing cisplatin with high-efficiency and low-toxicity treatment regimen". Considering the synergistic effect among radiotherapy, immunotherapy and anti-angiogenesis therapy, we chose PD-1 inhibitor combined with bevacizumab to replace cisplatin chemotherapy.

We plan to use PD-1 inhibitor combined with bevacizumab to replace cisplatin (induction + concurrent ± adjuvant) in patients with locally advanced nasopharyngeal carcinoma. Considering the safety of the original study, we will set up two groups for the adjuvant treatment stage: one group will only use PD-1 inhibitor at the adjuvant treatment stage (low risk group), and the other group will use bevacizumab +PD-1 inhibitor combined treatment (high risk group). Once the efficacy and safety of this protocol are confirmed, it may provide a new treatment option for locally advanced nasopharyngeal carcinoma.

PD-1 Blockade and Bevacizumab Replace Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma

PD-1 Inhibitor and Bevacizumab Replace Cisplatin in Induction, Concurrent, and/or Adjuvant Therapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma.

Incidence of nasopharyngeal necrosis or massive hemorrhage (grade ≥3).

Grade ≥3 hemorrhage: Grade 3, Transfusion indicated; invasive intervention indicated; hospitalization. Grade 4, Life-threatening consequences; urgent intervention indicated (e.g., tracheotomy or intubation). Grade 5, death.

Grade ≥3 nasopharyngeal necrosis: Grade 3, Severe pain; unable to adequately aliment or hydrate orally; limiting self care ADL. Grade 4, Life-threatening consequences; urgent intervention indicated.

Grade 5, death.

The proportion of patients whose tumors shrink to a certain size and maintain such size for a certain period of time, including patients with complete response (CR) and partial response (PR).

Progress-free survival is calculated from the date of enrollment to the date of the first progression at any site or death from any cause or censored at the date of the last follow-up.

Overall survival is calculated from the date of enrollment to the date of the death from any cause or censored at the date of the last follow-up.

Defined as the time from registration to local or regional relapse, or death from any cause.

Defined as the time from registration to distant metastasis, or death from any cause.

Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events (acute toxicity) and late radiation toxicities were assessed by CTCAE v5.0.

The First Hospital of Nanchang

Sun Yat-sen University

Chief physician, Proffessor

Patients will receive induction therapy (sintilimab + bevacizumab + gemcitabine, Q3W, 3 cycles) followed by IMRT+ Sintilimab. Consolidation therapy with sintilimab continued after radiotherapy until disease progression, intolerable toxicity, death, or the subject's decision to withdraw from the study, with a total treatment period of no more than 12 cycles.

This is a prospective, single-center, single-arm, phase II clinical study. The study was intended to include patients with locoregionally advanced nasopharyngeal cancer identified by histology or cytology, who signed informed consent and met the screening criteria to enter the study. Patients will receive induction therapy (sintilimab + bevacizumab + gemcitabine, Q3W, 3 cycles) followed by IMRT+ Sintilimab. Consolidation therapy with sintilimab continued after radiotherapy until disease progression, intolerable toxicity, death, or the subject's decision to withdraw from the study, with a total treatment period of no more than 12 cycles.

Sintilimab, bevacizumab, gemcitabine

IMRT

Platinum deplatinization has been extensively explored in patients with posterior nasopharyngeal carcinoma who have received multiple platinum treatments, including target-free combination, GEP, etc. Our center also published in 2022 CSCO a study on the preliminary efficacy of pembrolizumab combined with gemcitabine in the first-line treatment of metastatic NPC with or without cisplatin or anlotinib. Enrolled patients were treated with pembrolizumab + anlotinib +GP (group A), pembrolizumab +GP (group B), and pembrolizumab + anlotinib +G (group C), with ORR of 80% (4/5), 80% (4/5), and 100% (7/7), respectively. Among them, there were 1 CR and 6 PR in group C. Compared to group B, group C with anlotinib in place of cisplatin showed a better safety profile with fewer grade 3 adverse reactions (57.1% vs 100%). In summary, we designed this study to evaluate the efficacy and safety of gemcitabine, sintilimab and bevacizumab combined with IMRT in patients with advanced nasopharyngeal carcinoma not suitable for platinum-based treatment, and to explore new therapeutic approaches for patients with advanced stage nasopharyngeal carcinoma who cannot tolerate platinum therapy or are unwilling to receive platinum therapy.

This is a prospective, single-center, single-arm, phase II clinical study. The study was intended to include patients with locoregionally advanced nasopharyngeal cancer identified by histology or cytology, who signed informed consent and met the screening criteria to enter the study. Patients will receive induction therapy (sintilimab + bevacizumab + gemcitabine, Q3W, 3 cycles) followed by IMRT+ Sintilimab. Consolidation therapy with sintilimab continued after radiotherapy until disease progression, intolerable toxicity, death, or the subject's decision to withdraw from the study, with a total treatment period of no more than 12 cycles.

Sintilimab Combination Therapy Plus IMRT in Nasopharyngeal Carcinoma

Gemcitabine, Sintilimab, Bevacizumab Plus IMRT in Patients With Cisplatin Ineligible Locoregionally Advanced Nasopharyngeal Carcinoma

To evaluate the relationship between biomarkers and response

The time between the start of treatment and the first occurrence of any of the following events: disease progression, local or distant recurrence, death from any cause, whichever occurs first

Proportion of total subjects in complete response (CR) and partial response (PR)

Proportion of subjects defined as complete response (CR), partial response (PR), and stable disease (SD)

The time between the start of treatment and first radiographic disease progression or death, whichever occurs first

The time of treatment until the subject dies from any cause

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Zhejiang Cancer Hospital

chief physicians

Nutritional and Metabolic Diseases

Malnutrition

Nutrition Disorders

Docetaxel

Tubulin Modulators

Antimitotic Agents

Patients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin)

NC：cisplatin 75 mg/m2 intravenous infusion in day1，docetaxel 75 mg/m2 intravenous infusion in day1，both drugs are given every 3 weeks, two courses.

CCRT: intensity modulation radiation therapy(IMRT) and cisplatin (100mg/m2 on day 1) every three weeks for three\\three cycles during radiation therapy(RT).

Dietary supplement: enteral nutrition and parenteral nutrition

cisplatin and docetaxel

Chong Zhao, M.D

This is an prospective，open-label, none-interventional, observational， multicenter phase II clinical trial. The purpose of this study is to observe the effect of neoadjuvant chemotherapy followed by concurrent chemoradiation therapy(CCRT) on nutritional status in locoregionally advanced nasopharyngeal carcinoma(NPC) patients, analyse the changes of patients' nutrition status during the treatment and the connection between nutrition changes and curative effects, evaluate nutritional risks under the neoadjuvant chemotherapy and CCRT and provide data and basis for further study。

Effect of Chemoradiotherapy on Nutritional Status in Advanced NPC Patients

Effect of Neoadjuvant Chemotherapy Followed by Concurrent Chemo-radiotherapy on Nutritional Status in Locoregionally Advanced Nasopharyngeal Carcinoma Patients: Prospective Observational Study

To evaluate the acute toxicity with Common Terminology Criteria For Adverse Events (CTCAE) 3.0 when adjuvant chemotherapy and concurrent chemoradiation is used.

To observe patients' complete blood cell count and blood biochemical examination during the treatment and three years after the treatment.

Using European Organization for Research and Treatment of Cancer(EORTC) quality of life questionnaire(QLQ)-C30(version 3.0) and EORTC QLQ-H\&N35(Version 1.0) to access the quality of life. Collecting data before treatment, 1 week after each 4/5 cycles of chemotherapy, 3 years after all treatment finished.

To evaluate the late toxicity with the SOMA criterion after 1/2/3 years of treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PD-1 Blockade and Bevacizumab Replace Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma	NCT05341193	Nasopharyngeal ...	Bevacizumab+Tor... Bevacizumab+Tor...	18 Years - 65 Years	Sun Yat-sen University
PD-1 Blockade and Bevacizumab Replace Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma	NCT05341193	Nasopharyngeal ...	Bevacizumab+Tor... Bevacizumab+Tor...	18 Years - 65 Years	Sun Yat-sen University
Sintilimab Combination Therapy Plus IMRT in Nasopharyngeal Carcinoma	NCT06364826	Nasopharyngeal ...	Sintilimab, bev... IMRT	18 Years - 75 Years	Zhejiang Cancer Hospital
Effect of Chemoradiotherapy on Nutritional Status in Advanced NPC Patients	NCT02575547	Nasopharyngeal ... Malnutrition	cisplatin and d...	18 Years - 65 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for locoregionally advanced nasopharyngeal carcinoma