Combination Therapy for PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma: A Bayesian Adaptive Phase II Trial

PHASE2RecruitingINTERVENTIONAL
Enrollment

208

Participants

Timeline

Start Date

June 24, 2025

Primary Completion Date

January 30, 2027

Study Completion Date

January 30, 2028

Conditions
Recurrent or Metastatic Nasopharyngeal Carcinoma
Interventions
DRUG

Ivonescimab

Ivonescimab 10 mg/kg via intravenous infusion, until the occurrence of intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, loss to follow-up, or death, whichever occurs first.

DRUG

Nimotuzumab

Nimotuzumab 400 mg via intravenous infusion, Q3W, until the occurrence of intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, loss to follow-up, or death, whichever occurs first.

DRUG

Irinotecan liposome

Irinotecan liposome 50mg/m2 via intravenous infusion, D1, D15, Q4W for up to 6 cycles or until intolerable toxicity, subject withdrawal of informed consent, diseases progression, initiation of new antitumor therapy, loss of follow-up, or death, whichever occurs first.

DRUG

S-1

S-1, D1-D14, BID, p.o., (BSA \< 1.25 m2, 40 mg/dose; 1.25 m2 ⩽ BSA \< 1.5 m2, 50 mg/dose; BSA ⩾ 1.5 m2, 60mg/dose), Q4W for up to 6 cycles or until intolerable toxicity, subject withdrawal of informed consent, diseases progression, initiation of new antitumor therapy, loss of follow-up, or death, whichever occurs first.

DRUG

Mitoxantrone Hydrochloride Liposome

Mitoxantrone hydrochloride liposome 20mg/m2 via intravenous infusion, Q3W for up to 8 cycles or until intolerable toxicity, subject withdrawal of informed consent, diseases progression, initiation of new antitumor therapy, loss of follow-up, or death, whichever occurs first

DRUG

PD-1 Inhibitors

PD-1 blockade (comprising tislelizumab \<200 mg/cycle\>, carrellimab \<200 mg/cycle\>, or toripalimab \<240 mg/cycle\>) , Q3W for two years, or until intolerable toxicity, subject withdrawal of informed consent, diseases progression, initiation of new antitumor therapy, loss of follow-up, or death, whichever occurs first.

Trial Locations (6)

Unknown

NOT_YET_RECRUITING

Cancer Center of Guangzhou Medical University, Guangzhou

NOT_YET_RECRUITING

Guangdong Provincial People's Hospital, Guangzhou

NOT_YET_RECRUITING

Sun Yat-sen University Cancer Center, Guangzhou

NOT_YET_RECRUITING

Zhongshan People's Hospital, Zhongshan

RECRUITING

The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai

NOT_YET_RECRUITING

Xiangya Hospital, Central South University, Changsha

All Listed Sponsors
lead

Ming-Yuan Chen

OTHER

NCT07070479 - Combination Therapy for PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma: A Bayesian Adaptive Phase II Trial | Biotech Hunter | Biotech Hunter