Neoplasms

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Gestational Trophoblastic Disease

Trophoblastic Neoplasms

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Female Urogenital Diseases and Pregnancy Complications

Gestational Trophoblastic Tumor

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Population: ultra high-risk gestational trophoblastic neoplasia

Population: high-risk chemo-refractory or relapsed gestational trophoblastic neoplasia

Cohort A: Camrelizumab (200 mg q2w iv) concomitantly with apatinib (250 mg qd po) and EMA/CO \[etoposide, methotrexate, actinomycin D/cyclophosphamide, vincristine\] every 2 weeks. For certain patients with high tumor burden, 1-2 cycles of low-dose chemotherapy (actinomycin D 500 ug and etoposide 100mg/m2, D1-3) will be administered, then followed by EMA/CO. The observation period is 14 days.

Camrelizumab plus apatinib CohortA

Cohort B: Camrelizumab (200 mg q3w iv) concomitantly with apatinib (250 mg qd po) and multi-drug chemotherapy. The multi-drug chemotherapy regimen will be chosen by the investigator (chemotherapy regimen: EMA/CO \[etoposide, methotrexate, actinomycin D/cyclophosphamide, vincristine\]; or EMA/EP \[etoposide, methotrexate and actinomycin-D/etoposide, cisplatin\]; or FAEV \[floxuridine, actinomycin-D, etoposide, vincristine\]). The observation period is 21 days.

Camrelizumab plus apatinib Cohort B

Yang Xiang

xiang yang

The purpose of this study is to evaluate the efficacy and safety of camrelizumab and apatinib as combination therapy in patients with ultra high-risk (Cohort A) and high-risk chemo-refractory or relapsed (Cohort B) gestational trophoblastic neoplasia (GTN). Eligible patients will receive camrelizumab plus apatinib plus chemotherapy. Treatment will be continued until disease progression, unacceptable toxicity, or withdrawal of consent.

The purpose of this study is to evaluate the efficacy and safety of camrelizumab and apatinib as combination therapy in patients with ultra high-risk (Cohort A) and high-risk chemo-refractory or relapsed (Cohort B) gestational trophoblastic neoplasia (GTN).

Cohort A: Eligible patients will receive camrelizumab (200mg q2w iv) plus apatinib (250 mg qd po) plus chemotherapy. After normalization of serum β-human chorionic gonadotropin (β-hCG) levels, patients will receive 4 cycles of consolidation chemotherapy combined with camrelizumab plus apatinib and then 6 months of camrelizumab plus apatinib as maintenance treatment. Treatment will be continued until completion of treatment, disease progression, unacceptable toxicity, or withdrawal of consent.The primary endpoint is complete remission rate (the proportion of patients achieving complete remission). Secondary endpoints include objective response rate (the proportion of patients achieving complete remission and partial remission), progression-free survival (time from the treatment initiation to disease progression or death, whichever comes first), overall survival (time from the treatment initiation to the date of death or last follow-up), duration of response (time from the first evidence of response to disease progression or death, whichever comes first) and safety.

Cohort B: Eligible patients will receive camrelizumab (200mg q3w iv) plus apatinib (250 mg qd po) plus chemotherapy. Treatment will be continued until disease progression, unacceptable toxicity, or withdrawal of consent. Patients will receive 6 cycles of consolidation therapy if achieving a complete response. The primary endpoint is objective response rate. Secondary endpoints include progression-free survival, duration of response, overall survival and safety.

Camrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia

Camrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia: a Cohort, Open-label, Phase 2 Trial

The proportion of patients achieving complete remission. Complete remission is defined as normal serum β-hCG level measured for 3 consecutive weeks.

The proportion of patients with complete or partial response according to serum β-hCG level. Partial response is defined as a ≥50% decrease in β-hCG level from baseline after 2 cycles.

The proportion of patients with complete or partial response according to serum β-hCG level.

The time from the treatment initiation to disease progression or death, whichever comes first. Disease progression is defined as any increase in serum β-hCG level from baseline after 2 cycles of treatment or the presence of new metastatic lesions.

The time from the treatment initiation to the date of death or last follow-up.

The time from the first evidence of response to disease progression or death, whichever comes first.

Determine frequency and severity of adverse events as assessed by NCI CTCAE (Version 5.0) which is used to evaluate the grade of adverse events, to observe any adverse event and serious adverse event that occurred in all patients during the clinical study period, including abnormal laboratory examination results, clinical manifestations and vital signs, to record their clinical manifestation characteristics, severity, occurrence time, duration, corresponding treatment and prognosis, and to determine their relationship with the study drug.

The time from the treatment initiation to disease progression or death, whichever comes first.

Determine frequency and severity of adverse events as assessed by NCI CTCAE (Version 5.0) .

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Camrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia	NCT05139095	Gestational Tro...	Camrelizumab pl... Camrelizumab pl...	18 Years - 60 Years	Peking Union Medical College Hospital
Camrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia	NCT05139095	Gestational Tro...	Camrelizumab pl... Camrelizumab pl...	18 Years - 60 Years	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for camrelizumab plus apatinib cohort b