Adebrelimab plus concurrent chemoradiotherapy versus placebo for locally advanced cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase III trial compares adebrelimab (SHR-1316) given with standard concurrent chemoradiotherapy to placebo combined with the same chemoradiotherapy in people with locally advanced cervical cancer. Participants receive concurrent radiation with platinum- and taxane-based chemotherapy (cisplatin or carboplatin plus paclitaxel) and either adebrelimab or placebo injections. The primary endpoint is progression-free survival, with tumor response and safety monitored during and after treatment. Eligible participants must have a measurable lesion, ECOG performance status 0–1, adequate organ function, and no distant metastatic disease above the L1 vertebra or in the inguinal region.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participate in the study voluntarily, sign the informed consent form.
2. Subjects were able to provide primary or metastatic cancer samples.
3. At least one measurable lesion.
4. Expected survival \> 3 months.
5. ECOG 0 \~ 1.
6. With adequate organ functions.

Exclusion Criteria:

1. Pathologically or radiologically confirmed presence of distant metastatic disease, including lymph nodes above the first lumbar vertebra (L1) (cephalad) or in the inguinal region.
2. Administering live vaccines within 4 weeks before enrollment or during planned study treatment.
3. Participants who received immunosuppressive therapy within 4 weeks before enrolment.
4. For participants who are receiving thrombolytic/anticoagulant therapy, prophylactic anticoagulant therapy is allowed.
5. 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.
6. Known allergy to the investigational drug or any of its excipients; or severe allergic reaction to other monoclonal antibodies.
7. Pregnant or breastfeeding women.
8. According to the investigator's judgment, there are diseases or any other conditions that may seriously endanger the safety of the subjects, may confound the research results, or affect the subjects' ability to complete the study.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Xiaoxu Zhang
• Email: xiaoxu.zhang@hengrui.com
• Phone: +86-0518-82342973

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Propranolol with Adebrelimab and Platinum Chemotherapy in Small Cell Lung Cancer

  This early-phase trial tests whether adding propranolol to adebrelimab plus platinum chemotherapy is safe and may help treat small cell lung cancer in adults.

  Recruiting Phase 1 Second Xiangya Hospital of Central South University · Changsha, Hunan and 3 other locations · NCT07886047

• HS-20093 with Adebrelimab vs HS-20093 alone in advanced non-squamous NSCLC

  This study tests whether adding adebrelimab to HS-20093 helps patients with advanced non-squamous NSCLC who have already had treatment.

  Recruiting Phase 2 Hansoh BioMedical R&D Company · Wuhan, Hubei · NCT07824882

• Shrinkage-free combo in LS-SCLC: SHR-7787 plus SHR-1316

  This trial tests whether the combo of SHR-7787 and SHR-1316 can help adults with unresectable limited-stage small cell lung cancer after prior platinum-based chemo and radiation.

  Recruiting Phase 2 Shanghai Hengrui Pharmaceutical Co., Ltd. · Jinan, Shandong · NCT07798947

• Neoadjuvant therapy with adebrelimab, famitinib, and chemotherapy for resectable ESCC

  This study tests a combination of adebrelimab, famitinib, and chemotherapy before surgery in people with resectable locally advanced esophageal squamous cell carcinoma to see if it can lead to a complete tumor disappearance at the time of surgery.

  Recruiting Phase 2 First Affiliated Hospital Xi'an Jiaotong University · Xi'an, Shannxi · NCT07796113

• A combination therapy for advanced second-line gastric cancer using apatinib with albumin-bound paclitaxel, with or without adebrelimab

  This study tests whether adding adebrelimab to a regimen of apatinib and albumin-bound paclitaxel helps patients with advanced gastric or gastroesophageal junction cancer who did not respond to first-line therapy.

  Recruiting Phase 2 The First Affiliated Hospital of Zhengzhou University · Zhengzhou, Henan · NCT07770113

• Short-course radiotherapy with Adebrelimab and platinum chemo before surgery for locally advanced cervical cancer

  This trial tests a short course of radiotherapy combined with Adebrelimab and platinum chemotherapy to shrink locally advanced cervical cancer before surgery.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07731828

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.