Camrelizumab Clinical Trials

What Is Camrelizumab?

Camrelizumab is a medication that functions as a PD-1 monoclonal antibody. It works by targeting the PD-1 (Programmed Death-1) protein, which is found on immune cells. By blocking PD-1, Camrelizumab helps to unleash the body's immune system to recognize and fight cancer cells. This type of treatment is known as immunotherapy.

Camrelizumab was approved by the China State Food and Drug Administration (CFDA) in 2020 for the second-line treatment of hepatocellular carcinoma (HCC). It is also being investigated in numerous clinical trials for a wide range of other cancers. These include nasopharyngeal carcinoma, gastric cancer, esophageal cancer, breast cancer, and cervical cancer. Researchers are studying Camrelizumab both as a standalone treatment and in combination with other therapies, such as chemotherapy, targeted agents, and even oncolytic viruses, to explore its potential benefits across various advanced or metastatic solid tumors.

Uses and Conditions Under Study

Camrelizumab is currently being studied in a broad range of conditions, primarily various types of cancer, reflecting its role as an immunotherapy agent.

• Liver Cancers: Hepatocellular carcinoma (HCC) is a significant focus, with 29 trials investigating Camrelizumab. HCC is a common and aggressive liver cancer, and immunotherapies like Camrelizumab are being explored as crucial treatment options, especially in advanced stages. One trial notes that Camrelizumab was approved by the CFDA for second-line HCC in 2020.
• Head and Neck Cancers: This category includes nasopharyngeal carcinoma (18 trials) and head and neck squamous cell carcinoma (HNSCC) (7 trials). HNSCC accounts for a large percentage of head and neck cancers, with a 5-year survival rate of only 50% under standard treatment, highlighting the need for new therapies.
• Gastrointestinal Cancers: Camrelizumab is under investigation for gastric cancer (12 trials) and esophageal cancer, including esophageal squamous cell carcinoma (10 trials each). Gastric cancer is a common malignancy with limited options for advanced stages, and neoadjuvant chemotherapy combined with PD-1 antibodies is being explored to improve outcomes.
• Gynecological and Breast Cancers: Studies are also underway for breast cancer (9 trials) and cervical cancer (8 trials). For breast cancer, achieving pathological complete response after neoadjuvant chemotherapy is linked to improved outcomes, and Camrelizumab is being studied in these neoadjuvant settings.
• Other Cancers and Treatment Approaches: Beyond specific cancer types, Camrelizumab is broadly studied in the context of immunotherapy (18 trials) and in combination with chemotherapy (6 trials), indicating its potential across various solid tumors and as part of multi-modal treatment strategies.

Dosing

Camrelizumab is primarily administered as an intravenous (IV) infusion. Clinical trials have investigated various dosing regimens, often involving Camrelizumab as a single agent or in combination with other anti-cancer therapies.

A common dosage observed in studies is 200 mg of Camrelizumab, administered as an intravenous drip over approximately 0.5 hours, typically every 3 weeks (Q3W). This regimen has been studied in various contexts, including advanced or metastatic cancers.

Camrelizumab is frequently combined with other drugs, and its dosage remains consistent at 200 mg while the co-administered drugs vary in their forms and schedules. For instance, it has been studied with:

• Paclitaxel (albumin-bound) and Carboplatin, administered every 3 weeks.
• Ivarmacitinib tablets, taken orally daily during specific cycles.
• Apatinib, an oral targeted therapy, often in combination with Camrelizumab for conditions like hepatocellular carcinoma.
• Oncolytic viruses, such as H101, which are injected intratumorally.

Other combinations include various chemotherapies (e.g., FOLFOX, XELOX), other targeted agents (e.g., famitinib, rivoceranib, lenvatinib), and radiotherapy. While the specific doses of these combination drugs vary, the intravenous administration of Camrelizumab at 200 mg every 3 weeks is a consistently studied approach in adult patients. There is no specific information provided regarding pediatric dosing.

Side Effects

No specific side effect data for Camrelizumab was provided in the available clinical trial results.

Clinical Trial Results

Advanced Esophageal Cancer

In a study (NCT03099382) comparing Camrelizumab to investigator's choice of standard chemotherapy for participants with advanced esophageal cancer, Camrelizumab demonstrated an improvement in overall survival. Patients treated with Camrelizumab had a median overall survival of 8.28 months, compared to 6.24 months for those receiving standard therapy.

Locally Advanced Colon Cancer

A study (NCT04625803) investigating neoadjuvant therapy for locally advanced colon cancer reported specific outcomes. In this trial, 0 participants experienced mortality. Among patients with pMMR (mismatch repair proficient) tumors, 7 participants showed tumor regression.

Resectable Oral Squamous Cell Carcinoma

In a study (NCT04649476) evaluating neoadjuvant PD-1 blockade for resectable oral squamous cell carcinoma, two treatment approaches were examined: PD-1 blockade alone and PD-1 blockade combined with TPF induction chemotherapy.

For pathologic response:

• With neoadjuvant PD-1 blockade alone, participant counts for different response levels were 0, 25, 4, and 5.
• With neoadjuvant PD-1 blockade plus TPF induction chemotherapy, participant counts for different response levels were 2, 4, 26, and 2.

For radiographic response:

• With neoadjuvant PD-1 blockade alone, participant counts for different response levels were 3, 0, 0, 11, and 20.
• With neoadjuvant PD-1 blockade plus TPF induction chemotherapy, participant counts for different response levels were 0, 16, 14, 1, and 3.

Currently Recruiting Trials

• A Phase II/III study, NCT07589244, is evaluating VRT106 combined with Camrelizumab and Apatinib for advanced hepatocellular carcinoma (HCC) in patients who have previously received immune checkpoint inhibitors. This open-label trial aims to enroll 66 participants.
• For locally advanced low pMMR/MSS rectal cancer, a Phase II study (NCT07527026) is investigating Camrelizumab combined with long-course chemoradiotherapy as part of a total neoadjuvant therapy approach. The goal is to improve complete response rates and facilitate organ preservation for 44 patients.
• A large Phase II platform trial (NCT07328009) is recruiting 350 patients with advanced HCC after first-line treatment failure. This adaptive study efficiently evaluates novel therapies, including TUDCA combined with Camrelizumab and a TKI, to identify the most effective regimens.
• In locally advanced unresectable esophageal squamous cell carcinoma, NCT07530094 is a Phase II study comparing different short-course definitive chemoradiotherapy regimens combined with adjuvant or concurrent plus adjuvant Camrelizumab. This trial plans to enroll 98 individuals.
• An advanced triple-negative breast cancer Phase III trial (NCT06889688) is comparing Camrelizumab, Apatinib, and Eribulin against physician's choice chemotherapy. This study is recruiting 246 participants to assess improvements in progression-free and overall survival.
• For recurrent/metastatic nasopharyngeal carcinoma, a Phase III study (NCT06669611) is comparing Camrelizumab with Nab-TPC chemotherapy versus GP chemotherapy. This trial aims to enroll 242 patients.
• A Phase II/III trial (NCT06361888) is evaluating Surufatinib combined with Camrelizumab, Nab-paclitaxel, and Gemcitabine as a first-line treatment for metastatic pancreatic cancer. This study is designed for 502 participants.
• An Early Phase I study (NCT06326736) is investigating the safety and efficacy of surgery followed by Camrelizumab and personalized cancer mRNA vaccines for resectable pancreatic cancer, enrolling 12 patients.
• For advanced melanoma, a Phase I/II study (NCT05983237) is exploring Fluzoparib in combination with Camrelizumab and Temozolomide in patients with homologous recombination pathway gene mutations. This trial is recruiting 50 participants.
• A Phase II study (NCT05841472) is evaluating Camrelizumab in combination with Pemetrexed and Carboplatin as a first-line treatment for 60 patients with advanced or metastatic non-squamous non-small cell lung cancer.

Where to Participate

Development Timeline