Neoadjuvant Immunochemotherapy in PD-L1-negative LACC

NCT06288360 | Recruiting Phase 2 DMC

• 3 other identifiers: NACI-CERV-002MA-CervC-II-007[2024](S019)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 12

Brief Summary

This is a multicenter, prospective, single-arm, phase 2 clinical trial designed to evaluate the therapeutic efficacy of the NACI (neoadjuvant chemotherapy plus Camrelizumab) for PD-L1-negative locally advanced cervical cancer.

Conditions

Cervical Cancer; Locally Advanced Cervical Cancer; PD-L1 Negative; Neoadjuvant Chemoimmunotherapy

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response

  Pathologic complete response (pCR) refers to the absence of invasive/in situ cancer in the uterine cervix and/or lymph nodes

  undergoing surgery; up to 2 years.

Secondary Outcomes (7)

• Surgical Complications

  during and after surgery; an average of 3 years.

• Objective response rate

  measured 3 weeks after the last dose of neoadjuvant treatment and before surgery; up to 2 years.

• Positive surgical margin rate

  undergoing surgery; 2 years

• event-free survival

  7 years

• overall survival

  7 years

Study Arms (1)

Neoadjuvant chemotherapy plus camrelizumab (NACI)

EXPERIMENTAL

Patients first received one cycle of platinum-based doublet priming chemotherapy. After 3 weeks, participants received two cycles of the PD-1 inhibitor camrelizumab combined with chemotherapy every 3 weeks. Patients with stable disease or progressive disease received concurrent chemoradiotherapy, and patients with a complete response or partial response proceeded to radical surgery.

Drug: Camrelizumab; Drug: Paclitaxel-albumin; Drug: Cisplatin; Procedure: radical surgery

Interventions

Camrelizumab DRUG

200 mg, intravenously, 20-60 min. 2 times, every 21 days

Also known as: SHR-1210

Neoadjuvant chemotherapy plus camrelizumab (NACI)

Paclitaxel-albumin DRUG

260 mg/m² over 30 min, 3 times, every 21 days

Also known as: Injectable paclitaxel (albumin bound)

Neoadjuvant chemotherapy plus camrelizumab (NACI)

Cisplatin DRUG

4 h, 75-80 mg/m², 3 times, every 21 days

Also known as: Cisplatin injection

Neoadjuvant chemotherapy plus camrelizumab (NACI)

radical surgery PROCEDURE

Radical hysterectomy + pelvic lymphadenectomy 士 para-aortic lymphadenectomy

Neoadjuvant chemotherapy plus camrelizumab (NACI)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• FIGO 2018 stage IB3, IIA2, or IIB/IIIC1r (tumor size\>4cm) cervical cancer and without any treatment (After undergoing gynecological examinations by two associate chief physicians or above, the staging of the patients was determined);
• Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. In principle, the size of the lesion as shown by the magnetic resonance imaging examination is used as the criterion.
• Histologically confirmed squamous carcinoma, adenocarcinoma (common type) or adenosquamous carcinoma of the cervix;
• Negative PD-L1 expression on preoperative pathological examination (Combined positive score \< 1);
• years of age;
• Eastern Cooperative Oncology Group score ≤ 1;
• WBC≥3.5\*10\^9/L, NEU≥1.5\*10\^9/L, Platelet≥100×10\^9 /L; AST and ALT ≤1.5 times normal upper limit; Total bilirubin ≤1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen ≤the upper limit of normal value;
• Well-compliance and willing to keep in touch;
• Willing to participate in this study, sign the informed consent, and comply with the requirements and limitations outlined in the Informed Consent Form (ICF) and this form.

You may not qualify if:

• Active, known, or suspected autoimmune disease, or a history of an autoimmune disease, except for the following: vitiligo, alopecia areata, Graves's disease, psoriasis, or eczema that has not required systemic therapy within the last 2 years, hypothyroidism that is asymptomatic or requires only stable doses of hormone replacement therapy (due to autoimmune thyroiditis), type 1 diabetes that requires only stable doses of insulin replacement therapy, asthma that subsides completely in childhood and does not require intervention in adulthood, or diseases that do not recur in the absence of external triggers;
• Prior treatment with immune checkpoint inhibitors, including, but not limited to, other anti-PD-1, anti-PD-L1 antibodies, CTLA-4 antibodies, or antibodies against immune co-stimulators (e.g., antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.), or any other therapy targeting a tumor's immune mechanism of action;
• Known hypersensitivity to any component and/or any excipient of the trial prescribed medication;
• Immunosuppressive drugs or systemic corticosteroids for immunosuppression (\> mg/day of prednisone or other equivalent) within 2 weeks prior to trial dosing; topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids are permitted;
• Received herbs with antitumor effects or drugs with immunomodulatory effects (e.g., thymidine, interferon, interleukin-2) within 2 weeks prior to the trial;
• Active systemic infection requiring systemic treatment;
• Serious infection within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia;
• Patients with untreated chronic hepatitis B, or HBV carriers with chronic hepatitis B virus (HBV) DNA greater than 1,000 IU/mL, or patients with active hepatitis C. Inactive HBsAg carriers, patients with hepatitis B who have received treatment and are in stable condition (HBV \< 1000 IU/mL), and patients with cured hepatitis C are eligible for enrollment. HCV antibody-positive subjects will be eligible for the study only if they have a negative HCV RNA test;
• Immunodeficiency or human immunodeficiency virus (HIV antibody positive);
• Subjects with active inflammatory bowel disease or a history of such disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea). Subjects who are unable to swallow or who have malabsorption syndrome, uncontrolled nausea, vomiting, diarrhea, or other gastrointestinal disorders that severely interfere with drug intake and absorption;
• Known interstitial lung disease that is symptomatic or may interfere with detection or treatment of immune-associated pneumonia;
• Treatment with a live or attenuated vaccine administered within 4 weeks prior to the first trial dose, inactivated seasonal influenza virus vaccine is permitted;
• Have received a prior allogeneic bone marrow transplant or solid organ transplant;
• History of primary malignant tumor within the last 5 years;
• Have undergone major surgery (e.g., open abdomen, open chest, organ resection, etc.) and severe trauma within 28 days prior to the first dose of the implantable infusion device is permitted;

Sponsors & Collaborators

• Tongji Hospital: lead
• Southwest Hospital, China: collaborator
• Women's Hospital School Of Medicine Zhejiang University: collaborator
• Anhui Provincial Cancer Hospital: collaborator
• Sichuan Cancer Hospital and Research Institute: collaborator
• Gansu Provincial Maternal and Child Health Care Hospital: collaborator
• Beijing Friendship Hospital: collaborator
• Tianjin Medical University General Hospital: collaborator
• Xiangya Hospital of Central South University: collaborator
• West China Second University Hospital: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Zhejiang Cancer Hospital: collaborator
• Shengjing Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Cancer Hospital of Guangxi Medical University: collaborator

Study Sites (12)

Anhui Provincial Cancer Hospital

Hefei, Anhui, 230000, China

RECRUITING

Beiing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

The First Affiliated Hospital (Southwest Hospital), Army Medical University (Third Military Medical University)

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

Gansu Provincial Maternity and Child-care Hospital

Lanzhou, Gansu, 730050, China

RECRUITING

The Affiliated Tumor Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

RECRUITING

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

RECRUITING

Second People's Hospital of Sichuan (Sichuan Cancer Hospital)

Chengdu, Sichuan, 610041, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Women's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310022, China

RECRUITING

Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

camrelizumab; Cisplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Ding Ma

  Tongji Hospital

  STUDY CHAIR

Central Study Contacts

Kezhen Li

CONTACT

086-027-8362; tjkeke@126.com

Jie Yang

CONTACT

086-027-8362; yangjie@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: March 1, 2024
• Study Start: September 12, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 12, 2030
• Last Updated: March 20, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)