Clinical trial · Interventional
Camrelizumab Combined With Chemotherapy for Recurrent or Advanced Cervical Neuroendocrine Carcinomas
Anti-PD-1 Antibody Camrelizumab Combined With Cisplatin/Paclitaxel/Bevacizumab for Recurrent or Advanced Cervical Neuroendocrine Carcinomas: A Single Arm, Phase II Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Recurrent or advanced cervical neuroendocrine carcinoma (NEC) is refractory to multimodal treatment, even to extensive therapy. Chemotherapy, consisting of platinum and etoposide, remains the main therapy for recurrent or advanced cervical NEC. In addition, bevacizumab has shown progression-free benefits in recurrent or advanced cervical cancer. Case report suggested anti-PD-1 antibody may have antitumor activities in NEC. Based on these evidences, a phase 2, single arm trial is conducted to explore the objective response rate (ORR) of platinum/etoposide/bevacizumab/anti-PD-1 antibody (camrelizumab) for the treatment of recurrent or advanced cervical NEC. This trial is to enroll 20 patients, who would accept 6 courses of platinum/etoposide/bevacizumab/camrelizumab. If the patient achieved complete or partial remission, a total period of 12 months bevacizumab/camrelizumab will be given as maintain therapy. The primary endpoint is ORR. The second endpoints are severe adverse events according to criteria of Common Terminology Criteria for Adverse Events (CTCAE) and iRECIST Guideline, and critical changes of laboratory testing.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cervical Carcinoma | Cervical Carcinoma | CURATED_BROADER | 0.78 |
| Adverse Drug Event | — | UNRESOLVED | — |
| Anti-pd-1 Antibody | — | UNRESOLVED | — |
| Cervical Neuroendocrine Carcinoma | Cervical Neuroendocrine Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Chemotherapy | — | UNRESOLVED | — |
| Objective Response Rate | — | UNRESOLVED | — |
| Recurrent Cervical Carcinoma | Cervical Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drug therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study group
- description
- Patients will accept therapy consisting of platinum/etoposide/bevacizumab/camrelizumab
- interventionNames
- Drug: Drug therapy
Primary outcomes (1)
- measure
- objective response rate
- timeFrame
- 1 years
- description
- proportion of partial or complete remission after intervention
Secondary outcomes (2)
- measure
- severe adverse events
- timeFrame
- 1 year
- description
- grade 3/4 adverse events and mortality according to criteria of Common Terminology Criteria for Adverse Events (CTCAE) and iRECIST Guideline
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed recurrent or advanced cervical neuroendocrine carcinoma * Aged 18 years or older * No immunosuppressive disease * Signed an approved informed consents * Performance status of ECOG 0-1 Exclusion Criteria: * Not meeting all of the inclusion criteria
References
Publications (0)
Data not yet available