Trial comparing treatments for Advanced Cervical Cancer
Official title A Phase III Clinical Study of Adebrelimab Combined With Concurrent Chemoradiotherapy Versus Placebo Combined With Concurrent Chemoradiotherapy for the Treatment of Locally Advanced Cervical Cancer
ClinicalTrials.gov ID: NCT07168200
What this study is testing
What is SHR-1316 Injection?
SHR-1316 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for advanced cervical cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to look at how well it works of Adebrelimab plus concurrent chemoradiotherapy compared with placebo plus concurrent chemoradiotherapy for the treatment of locally advanced cervical cancer by evaluating progression-free survival (PFS).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Participate in the study voluntarily, sign the informed consent form.
- people were able to provide primary or metastatic cancer samples.
- At least one measurable lesion.
- Expected survival \> 3 months.
- ECOG 0 \~ 1.
You likely can't join if
- Pathologically or radiologically confirmed presence of distant metastatic disease, including lymph nodes above the first lumbar vertebra (L1)...
- Administering live vaccines within 4 weeks before enrollment or during planned study treatment.
- Participants who received immunosuppressive therapy within 4 weeks before enrolment.
- For participants who are receiving thrombolytic/anticoagulant therapy, prophylactic anticoagulant therapy is allowed.
- Participants who have had other uncured malignant tumors in the past (within 5 years) or concurrently have had other uncured malignant tumors...
- Known allergy to the investigational drug or any of its excipients; or severe allergic reaction to other monoclonal antibodies.
See the full eligibility criteria
- Participate in the study voluntarily, sign the informed consent form.
- people were able to provide primary or metastatic cancer samples.
- At least one measurable lesion.
- Expected survival \> 3 months.
- ECOG 0 \~ 1.
- With adequate organ functions.
- Pathologically or radiologically confirmed presence of distant metastatic disease, including lymph nodes above the first lumbar vertebra (L1) (cephalad) or in the inguinal region.
- Administering live vaccines within 4 weeks before enrollment or during planned study treatment.
- Participants who received immunosuppressive therapy within 4 weeks before enrolment.
- For participants who are receiving thrombolytic/anticoagulant therapy, prophylactic anticoagulant therapy is allowed.
- Participants who have had other uncured malignant tumors in the past (within 5 years) or concurrently have had other uncured malignant tumors, excluding cured basal cell carcinoma of the skin and carcinoma in situ.
- Known allergy to the investigational drug or any of its excipients; or severe allergic reaction to other monoclonal antibodies.
- Pregnant or breastfeeding women.
- According to the investigator's judgment, there are diseases or any other conditions that may seriously endanger the safety of the people, may confound the research results, or affect the people' ability to complete the...
The study team makes the final eligibility decision.
Where it is enrolling
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.