QL1706 Combined With Cisplatin/Paclitaxel as Neoadjuvant Therapy for Cervical Cancer
A Phase II, Single-Arm Study of QL1706 Combined With Cisplatin/Paclitaxel as Neoadjuvant Therapy Prior to Conservative Surgery for FIGO 2018 Stage IB1-IB3 Cervical Cancer (CERVINA Study)
This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of QL1706 combined with cisplatin and paclitaxel as neoadjuvant therapy in patients with FIGO 2018 stage IB1-IB3 cervical cancer undergoing conservative surgery.
The primary endpoint is pathological complete response (pCR). Secondary endpoints include objective response rate (ORR), progression-free survival (PFS), overall survival (OS), 3-year pelvic recurrence rate, and safety profile.
Additionally, exploratory biomarker analyses will be conducted to investigate changes in immune status, genomic alterations, PD-L1 expression, tumor mutational burden, MSI-H/dMMR status, and vaginal microbiota before and after treatment.
연구 개요
상태
상세 설명
Cervical cancer remains one of the most common gynecologic malignancies worldwide. Neoadjuvant chemotherapy (NACT) has demonstrated favorable response rates in locally advanced cervical cancer; however, pathological complete response (pCR) rates remain limited.
QL1706 is a novel bifunctional PD-1/CTLA-4 antibody combination developed using the MabPair® platform. It consists of the anti-PD-1 antibody iparomlimab and the anti-CTLA-4 antibody tuvonralimab. Previous studies have demonstrated promising antitumor activity in recurrent or metastatic cervical cancer.
This study aims to investigate whether the addition of QL1706 to cisplatin/paclitaxel neoadjuvant therapy can improve pathological response and clinical outcomes in patients with FIGO 2018 stage IB1-IB3 cervical cancer undergoing conservative surgery.
Approximately 50 patients will be enrolled. Eligible patients will receive neoadjuvant QL1706 combined with cisplatin and paclitaxel followed by radical surgery. Efficacy will be evaluated using RECIST v1.1 and pathological assessment. Safety will be assessed according to CTCAE v5.0.
Exploratory translational studies will evaluate immune microenvironment changes, molecular biomarkers, and vaginal microbiota alterations associated with treatment response.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Zhigang Zhang, MD
- 전화번호: 86057189713631
- 이메일: zzg2011@zju.edu.cn
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Female patients aged 18-65 years.
- Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
- FIGO 2018 stage IB1, IB2, or IB3 cervical cancer.
- Pelvic MRI completed before enrollment.
- ECOG performance status of 0-2.
- Adequate organ and bone marrow function.
- No prior immunotherapy for malignant tumors.
- Ability to understand and willingness to sign written informed consent.
Exclusion Criteria:
- Presence of uncontrolled concomitant malignancies.
- Active autoimmune disease or history of autoimmune disease with potential recurrence.
- Interstitial lung disease or uncontrolled pneumonitis.
- Active hepatitis B or hepatitis C infection.
- Known HIV infection.
- Receipt of live vaccines within 30 days before first dose.
- Uncontrolled cardiovascular disease.
- Known hypersensitivity to study drugs.
- Any condition that, in the investigator's judgment, may interfere with study participation or interpretation of results.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Experimental Arm
QL1706 + Cisplatin/Paclitaxel Neoadjuvant Therapy
|
QL1706 is a bifunctional PD-1/CTLA-4 antibody combination consisting of iparomlimab and tuvonralimab. Drug: Cisplatin Cisplatin administered as part of neoadjuvant chemotherapy. Drug: Paclitaxel Paclitaxel administered as part of neoadjuvant chemotherapy. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pathological Complete Response (pCR)
기간: At surgery following completion of neoadjuvant therapy
|
Proportion of patients achieving pathological complete response after neoadjuvant therapy.
|
At surgery following completion of neoadjuvant therapy
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Objective Response Rate (ORR)
기간: During neoadjuvant treatment period
|
Proportion of patients achieving complete or partial response according to RECIST v1.1.
|
During neoadjuvant treatment period
|
|
Progression-Free Survival (PFS)
기간: Up to 3 years
|
Time from treatment initiation to disease progression or death.
|
Up to 3 years
|
|
3-Year Pelvic Recurrence Rate
기간: 3 years
|
Proportion of patients with pelvic recurrence within 3 years.
|
3 years
|
|
Adverse Events
기간: From informed consent through 30 days after last treatment dose
|
Incidence and severity of adverse events graded according to CTCAE v5.0.
|
From informed consent through 30 days after last treatment dose
|
|
Overall Survival (OS)
기간: Up to 3 years
|
Time from treatment initiation to death from any cause
|
Up to 3 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jianwei Zhou, PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CERVINA Study
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
자궁 경부암에 대한 임상 시험
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen Breast Cancer...완전한
-
University of UtahNational Cancer Institute (NCI)완전한피로 | 좌식 생활 | 전이성 전립선암 | IV기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVA기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVB기 전립선암 AJCC(American Joint Committee on Cancer) v8미국
-
SB Istanbul Education and Research Hospital아직 모집하지 않음Thryoid cancer | parathyrıoid 선종
-
Jonsson Comprehensive Cancer CenterNovartis Pharmaceuticals모병전립선암 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center모병전립선 선암종 | 2기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center빼는전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer CenterMiraDX모집하지 않고 적극적으로전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Society for Endocrinology초대로 등록
-
Jonsson Comprehensive Cancer Center모병거세저항성 전립선암 | 전이성 전립선암 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center종료됨거세저항성 전립선암 | 전이성 전립선암 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
QL1706 + Cisplatin/Paclitaxel Neoadjuvant Therapy에 대한 임상 시험
-
University of California, DavisNational Cancer Institute (NCI)아직 모집하지 않음
-
The First Affiliated Hospital of Xiamen University아직 모집하지 않음
-
Peking University Cancer Hospital & Institute모병
-
RenJi Hospital모병HR-positive/HER2-negative Breast Cancer중국
-
Peking University Cancer Hospital & Institute모병
-
Cancer Institute and Hospital, Chinese Academy...모병
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityThe Third Affiliated Hospital of Guangzhou Medical University; Guangzhou First People's... 그리고 다른 협력자들모병