Actively Recruiting
IN10018 With Nab-Paclitaxel and Cadonilimab for Metastatic or Recurrent Gastric-Type Cervical Adenocarcinoma: Phase 2 Trial
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-01-13
25
Participants Needed
2
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Gastric-type adenocarcinoma of the cervix is the most commonly diagnosed HPV-independent subtype of cervical cancer, characterized by a poor prognosis and limited responsiveness to existing therapies. Therefore, the exploration of new treatment modalities is critically important. This is an open-label, single-arm, multi-center clinical trial to evaluate the efficacy and safety of IN10018 plus nab-paclitaxel and cadonilimab in the treatment of adult women with metastatic, recurrent, or persistent gastric-type adenocarcinoma of the cervix.
CONDITIONS
Official Title
IN10018 With Nab-Paclitaxel and Cadonilimab for Metastatic or Recurrent Gastric-Type Cervical Adenocarcinoma: Phase 2 Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 75 years
- Metastatic, recurrent, or persistent gastric-type adenocarcinoma of the cervix not curable by surgery or radiation
- At least one prior systemic chemotherapy regimen for metastatic, recurrent, or persistent cervical cancer (prior adjuvant therapy does not count)
- Measurable disease per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy longer than 3 months
- Side effects from previous treatments resolved to Grade 1 or baseline; neuropathy up to Grade 2 is allowed
- Adequate blood counts and organ function including neutrophils, platelets, hemoglobin, kidney, liver, and coagulation parameters
- Negative pregnancy test for females of childbearing potential and use of effective contraception during the study and for 6 months after last dose
- Willingness to participate and sign informed consent
You will not qualify if you...
- Cervical cancer types other than gastric-type adenocarcinoma, including squamous cell carcinoma, usual-type adenocarcinoma, clear cell carcinoma, adenosquamous carcinoma, and small cell carcinoma
- Participation in other drug clinical trials concurrently
- Known allergies to IN10018 or cadonilimab
- Active autoimmune disease or history of autoimmune disorders
- Need for immunosuppressive medications or high-dose corticosteroids recently
- HIV infection or AIDS diagnosis
- History of allogeneic organ or stem cell transplantation
- Necrotic lesions with high bleeding risk
- Severe infections within 4 weeks before treatment
- Active or suspected tuberculosis
- Untreated or active hepatitis B or C infections
- Known leptomeningeal disease, spinal cord compression, or active brain metastases
- Uncontrolled serious medical conditions that prevent safe study participation
- Live vaccine administration within 4 weeks before treatment (inactive flu vaccine allowed)
- Pregnancy, breastfeeding, or refusal to use contraception if applicable
- Symptomatic or unstable fluid accumulations needing repeated drainage
- Genetic mutations linked to rapid disease progression with immunotherapy (e.g., MDM2/4 amplification, EGFR mutations)
- Investigator judgment deeming participant ineligible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
2
Xiangyang Central Hospital
Xiangyang, Hubei, China, 441000
Actively Recruiting
Research Team
P
Peng Wu, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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